KR102051719B1 - Intragastric device for treating obesity - Google Patents

Abstract

Gastrointestinal devices for treating obesity include three-dimensional porous structures that are configurable between a compressed pre-deployed form and an expanded post-deployed form to facilitate delivery. The porous structure includes a first opening at its proximal end and a larger second opening at its distal end. The porous structure also includes a sleeve coupled to its distal end. Optionally, the device further includes a seal at the proximal end of the wire mesh structure and a movement preventing component located at the junction of the sleeve and the porous structure to facilitate recovery. The porous structure is deployed in the patient's stomach such that the movement preventing component rests proximally to the patient's pylorus and prevents the entire movement of the device into and through the pylorus. The sleeve extends through the pylorus into the duodenum and ends in the duodenum or jejunum. The food enters the device from the first opening at the proximal end of the porous structure, passes through the porous structure and the sleeve, and exits at the distal end of the sleeve. The device treats obesity by providing a volume charge structure that is relatively fixed in the stomach and a bypass for food passing through the pyloric and proximal parts of the small intestine. Optionally, the device also acts to slow down food passing through the digestive tract. Patients with devices experience a fuller feeling of satiety and a longer feeling of satiety.

Description

Gastrointestinal device for the treatment of obesity {INTRAGASTRIC DEVICE FOR TREATING OBESITY}

Cross reference

This application is directed to U.S. Provisional Patent Application No. 62 / 158,406, entitled "Gastrointestinal Device for the Treatment of Obesity," filed May 7, 2015, and U.S. Provisional Patent Application, filed September 23, 2014. Claims priority to heading 62 / 054,230.

The present application also discloses U.S. Provisional Patent Application No. 61 / 884,981, filed September 30, 2013 entitled "Gastrointestinal Device for Treatment of Obesity," and "Obe, filed March 14, 2013," Of U.S. Patent Application No. 14 / 214,609, filed March 14, 2014, which claims priority to U.S. Provisional Patent Application 61 / 782,564, "Therapeutic Intragastric Device". Partial continuous application.

US patent application Ser. No. 14 / 214,609 is also filed June 13, 2010 and US Patent No. 8,628,554, issued January 14, 2014, entitled " Gastrointestinal Device for Treatment of Obesity " US Patent Application No. 14 / 096,505 of the same name, filed December 4, 2013, filed on December 4, 2013, which is a serial application of / 814,481.

All of the above applications are incorporated herein by reference in their entirety.

Technical field

The present disclosure generally relates to medical devices useful for the treatment of obesity. More specifically, the present disclosure is directed to dynamic intragastric and gastrointestinal devices that result in patient weight loss by reducing gastric volume, slowing gastric emptying and / or bypassing portions of the small intestine.

Obesity is a common symptom and a growing public health problem in developed countries, including the United States. As of 2009, approximately 127 million people, more than two thirds of US adults, were overweight or obese. Over one third of American adults are obese. The data suggest that each year 300,000 Americans die prematurely from obesity-related complications. Many children in the United States are overweight or obese. Thus, the overall figure of overweight Americans is expected to rise in the future. It is estimated that the US spends more than $ 100 billion annually on obesity due to direct and indirect health care costs and lost productivity. This trend is also evident in many other developed countries.

For adults, body mass index (BMI) is used to determine whether overweight or obese. The human BMI is calculated by multiplying the body weight in pounds by 703 and then dividing the total by the height in inches squared. Human BMI is expressed in kg / m ² . Adults are considered overweight if their BMI is between 25 and 30 kg / m ² . Obesity is defined as having a BMI between 30 and 40 kg / m ² . BMIs greater than 30 kg / m ² are associated with significant comorbidities. Pathological obesity is defined as having a body weight greater than 100 pounds above the ideal value or a BMI greater than 40 kg / m ² . Approximately 5% of the US population meets at least one of the criteria for morbid obesity. Pathological obesity is, for example, diabetes; High blood pressure; heart attack; stroke; Dyslipidemia; Sleep apnea; Pickwick syndrome; asthma; Lower back and disc disease; Weight bearing osteoarthritis of hips, knees, ankles and feet; Thrombophlebitis and pulmonary embolism; Interstitial dermatitis; Stress incontinence; Gastroesophageal reflux disease (GERD); It is associated with a number of diseases and disorders, including gallstones and cirrhosis and carcinoma of the liver. In women, infertility, uterine cancer and breast cancer are additionally associated with pathological obesity. Taken together, diseases associated with pathological obesity significantly reduce the response costs of achieving life expectancy. Leukemia increases the annual mortality rate of a diseased person by more than 10 times.

Current treatments for obesity include diet, exercise, behavioral therapy, medicine, surgery (laparotomy and laparoscopic), and endoscopic devices. New drug treatments for obesity are currently being evaluated in clinical trials. However, high efficiency drug treatments have not yet been developed. In addition, short-term and long-term side effects of current drug treatments are often a problem for consumers, drug providers and / or their insurers. In general, diet or drug therapy programs continue to fall short of expectations and do not cause significant and lasting weight loss in the majority of people who are morbidly obese.

Currently, most surgeries used to treat pathological obesity include gastric limiting procedures, which are small (eg 15-35 ml) upper draining through small outlets (eg 0.75-1.2 cm). It involves creating a stomach pouch that moves the body's satiety mechanism. For stomach restriction procedures with malabsorption procedures, the conventional malabsorption procedure divides the small intestinal flow into gallbladder-interfering and food conduits. Potential long-term side effects associated with abdominal surgical procedures include hernia and small intestine occlusion. In addition, long-term problems specific to obesity procedures also include gastric outlet obstruction, marginal ulcers, protein malnutrition and vitamin deficiency.

Other surgical strategies for treating obesity include endoscopic procedures, many of which are still under development. Endoscopic procedures and devices for generating gastric pouch and gastric anastomosis anastomosis are used to mimic laparoscopic procedures. Endoscopically placed stomach balloons limit stomach volume and cause satiety with small meals. As an example, U.S. Patent Application No. 10 / 221,562, now assigned U.S. Patent 7,172,613 and assigned to Districlass Medical SA, describes as follows. "The gastrointestinal device is inserted by the endoscope path into the patient's stomach. The device includes a balloon or envelope with a specific nominal volume. The balloon is a disk that forms a support base for the balloon against the inner wall of the stomach. The device also includes a flexible tube or catheter for connecting the balloon to the capture device integral with the filling device and the tube or catheter. And / or remove and secure to the filling device inside or subcutaneously of the patient, and allow the balloon or envelope to reach its predetermined nominal volume. "

Silicone Intragastric Balloon (IGB) is a temporary aid to achieve weight loss specifically for those who weigh more than 40% of their ideal weight and are not satisfied with the results of their obesity treatment despite management by multiple specialist teams. Was developed as. Such treatment is also desirable for pathological obese patients who have a high morbidity and mortality risk for surgery. Placement and removal of IGB is an endoscopic procedure and the balloon is designed to float freely inside the stomach. IGB technology reduces the volume of the stomach and leads to premature satiety. However, the use of IGBs does not provide reliable evidence of greater weight loss. The associated risks for minor complications, such as gastric ulcer and barking, have been significantly increased. All inflatable IGB devices suffer from balloon deterioration over time. This deterioration can lead to contractions, which can lead to complications such as reduced small bowel obstruction resulting in reduced efficiency and balloon migration. Due to the loss of efficiency over time, IGB devices are only recommended for short (less than six months) periods. In addition, the rapid expansion of the balloon presents a risk of esophageal and gastric perforation, both of which are emergencies requiring surgery. Death was reported in patients using IGB treatment.

Endoscopic procedures are also used to deploy the mesh structure within the stomach in an effort to occupy the stomach volume and create an artificial satiety. As an example, US Patent Application No. 11 / 657,231, assigned to Wilson-Cook Medical, Inc., describes the following: "The intragastric device generally includes a strip non-digestible mesh material that can operate between the first and second configurations. The first configuration is sufficient to allow introduction of the non-digestible mesh material into the stomach lumen of the mammal. Small. The second configuration is large enough to prevent the non-digestible mesh material from passing through the mammalian pylorus, thereby allowing the mesh member to act as an artificial gastrometer. "

Although endoscopically placed balloon structures are valid, they are not without their associated risks and complications. Mesh structures are effective in occupying available gastric volume, but they do not solve gastric emptying. Migration from these devices and obstruction of the small intestine remain a significant problem. Thus, there is a need for an intragastric device for the treatment of obesity that combines the benefits obtained through gastric volume reduction, gastric emptying slowing, and the provision of a bypass of food that is part of the small intestine and the pyloric food while remaining relatively safe. Such devices should also include components to prevent migration of the entire device out of the stomach. Such devices have limited side effects and should be able to deploy and eliminate in a non-invasive manner relatively easily. In addition, such devices should have the option of treating additional obesity by including the benefits obtained by the malabsorption procedure. The addition of this optional benefit makes the device equally effective for type II diabetes as well as obesity.

Conventional metal structures cannot survive in hostile environments, especially with regard to the high acidity of the stomach. Intragastric devices that include acid sensitive components, such as metal wires, are typically coated or coated with an acid resistant material (ie, silicon) to prevent degradation of these components by acidic gastric contents. Conventional manufacturing processes for producing these coated intragastric devices first coat the metal wire of the device, and then form the wire into the desired final shape of the device. As the shape and structure of the gastric device become more complex, these conventional processes may not adequately produce the desired end product. Shape memory metals such as nitinol are thermally set at temperatures above 400 ° C. Coating of the metal with the acid resistant material and subsequent heat setting to the final shape results in breakage of the coating during exposure to high temperatures. Therefore, there is a need for a manufacturing method in which the wire of the gastric device is first formed into the desired final shape and then coated with a corrosion resistant material. This method should be managed to prevent coating and covering or clogging of the spaces or openings between the wires of the wire mesh. This method will also produce a final device that is still flexible enough to be converted from the compressed predeployed form to the expanded postdeployed form.

Certain surgical options for the treatment of obesity also include laparoscopic sleeve gastrectomy (LSG) and roux-en-y-gastric bypass (RGB) surgery. Gastrectomy refers to partial or total surgical removal of the stomach. LSG is a limiting treatment, surgical weight loss procedure, where the stomach is reduced to approximately 25% of its original size by surgical removal of a large portion along the main curve. The open edges are then attached together (often with a surgical stapler) to form a banana shaped sleeve or tube. This procedure permanently reduces the size of the stomach. This procedure is performed laparoscopically and is not reversible. After surgery, the stomach quickly drains its contents into the small intestine, but there is no vomiting (characteristic of other restrictive procedures).

LSG involves longitudinal ablation of the stomach on the Taiwanese valley from the room starting from the opposite side of the Latarjet nerve to the angle of His. The first stage of this procedure is the division of the gastrointestinal vasculature supply, which is achieved by cutting of the gastro- colon and gastric-splenic ligaments proximal to the stomach. The Taiwanese song is completely removed to the left leg of the diagram, cutting off the gastric floor containing the gastric ghrelin-secreting cells. The second step of this procedure is longitudinal gastrectomy, which "sleeves" the stomach to reduce the gastrointestinal shape to a narrow tube. Part of the pylorus and chamber are preserved resulting in a curvature-based "limiting" stomach sleeve.

Gastric sleeve resection (also referred to as gastric sleeve) is generally performed on extremely obese patients with a body mass index of 40 or greater if the risk of performing a gastric bypass or duodenal conversion procedure can be too high. A two-step procedure is carried out: the first procedure is gastric resection; The second procedure is conversion to gastric bypass or duodenal conversion. Patients generally lose much of their excess body weight after the first gastrectomy procedure, but if weight loss ceases, a second step is performed.

For obese but not highly obese patients, gastrectomy alone is an appropriate surgery with minimal risk. Gastric resection is currently an acceptable weight loss surgical option for obese patients as a single procedure. Most physicians prefer to use a dilator (tapered cylindrical instrument) with an outer diameter between 32-60 French (optimal dilator size is 32 Fr-36 Fr) in the procedure. The ideal estimated residual dose of the stomach after the procedure is 15 ml.

One of the mechanisms involved in weight loss observed after LSG is a dramatic decrease in gastrointestinal capacity. The concept of restriction is widely used for obesity treatment surgery in vertical banded gastroplasty (VBG) and laparoscopic adjustable gastric banding (LAGB). The expansion of small gastric pouches in the LAGB procedure or VBG is intended to take into account the premature feeling of fullness, improved satiety, and reduced hunger after ingestion of small amounts of food.

Hormonal changes induced by LSG are different from those found after pure restriction procedures such as LAGB. Gernin, a peptide hormone mainly produced at the bottom of the stomach, is believed to be involved in mechanisms that regulate hunger. There is a marked decrease in gerlin associated with ablation of the gastric floor.

What makes LSG a desirable option lies in the fact that this surgery is a simple procedure that can be completed laparoscopically, even in extreme obese patients. No gastrointestinal anastomosis is involved and no mesenteric defects are created, eliminating the risk of internal hernias. In addition, no foreign material is used as in the case of gastric banding, and the entire digestive tract remains accessible endoscopically and is not associated with dumping syndrome. In addition, the risk of peptic ulcer is low and the absorption of nutrients, vitamins, minerals and drugs is not altered.

Initial reports on LSG showed that it was safe and effective, with significant reductions in weight loss and major obesity-related comorbidities. The question of whether LSG can act as a single obesity treatment procedure in the long term is still unanswered. Because of this, LSG has a very high BMI (ultra obesity = BMI> 50 or hyper-second obesity = BMI> 60) and / or biliary diversion due to duodenal diversion (BPD-DS) or RGB due to linkage disease This is proposed as the first step of the staged approach in patients who seem too dangerous.

Laparoscopic Luwai gastric bypass (RGB) involves the production of small (20-30 ml) gastric pouches and roux limbs (typically 75-105 cm), with the lupus of the digestive tract to bypass the distal gastric and proximal small intestine. Reroute some. Following RGB, the multimodal endocrine response contributes to improved blood sugar control, decreased appetite and long-term changes in body weight. RGB also has a significant positive impact on obesity-related comorbidities and quality of life. Other advantages include continued weight loss, reduced comorbidity, minimal risk for long-term nutritional sequelae, and proven long-term effectiveness for effective relief against GERD. RGB is not not dangerous. Common causes of death include pulmonary embolism and connective leakage. Complications during pitch injuries include connection leakage, venous thromboembolism, lesion infection, small intestine occlusion and bleeding. Postoperative gastrointestinal complications include nausea and vomiting, micronutrient deficiency and possible weight gain.

Failures after these obesity treatment procedures are common and patients begin to gain weight again or stop gradual weight loss below the therapeutic level. Thus, structural therapy is needed after one or more failed obesity treatment procedures. What is needed is a device for use after obesity treatment surgery that combines the advantages of gastric volume reduction, gallbladder-interest conversion, and / or bowel bypass to improve the weight loss effect of the device. There is also a need for a device that further reduces the volume of surgically restricted stomach to reduce the amount of calories that can be consumed. Such devices also bypass the proximal small intestine or intestinal bleeding to produce intestinal malabsorption, gallbladder-interversion or both. The device may further act to delay gastric emptying, release gastric hormones associated with satiety, and stimulate gastric nerves associated with a sense of satiety. The device may be combined with other therapeutic aids, such as electrical stimulation, magnetic stimulation, or drug adjuvants.

The device can be used as a bridge to surgery for a permanent weight loss procedure or as a primary treatment procedure for weight loss. The device may also be used for the treatment of other conditions, including but not limited to metabolic syndrome, diabetes, dyslipidemia and cardiovascular disease.

The present disclosure discloses a delivery device for delivering a gastrointestinal device into a gastrointestinal tract of a patient, the gastrointestinal device comprising a porous structure configurable between a compressed pre-expanded form and an expanded post-development form and adjacent to the distal end of the porous structure. An elongate sleeve coupled to the anti-movement collar and the distal end of the porous structure, the delivery device comprising: a flexible outer catheter having a proximal end, a distal end, and a lumen; A flexible inner catheter having a lumen configured to slidably receive the proximal end, distal end, and guide wire, the inner catheter being coaxially positioned and configured to be slidably movable within the lumen of the outer catheter ; The outer catheter is configured to retract in the proximal direction above the inner catheter while holding the inner catheter in place to expose the gastrointestinal device from the distal end of the delivery device.

Optionally, the sleeve has a length such that once the gastrointestinal tract device is delivered, the proximal end of the sleeve is located close to the patient's pylorus and the proximal end of the sleeve is located within a portion of the duodenum of the patient.

Optionally, the outer catheter has a length of approximately 1.5 meters and the delivery device has a total length of approximately 3 meters.

Optionally, the anti-movement collar of the gastrointestinal tract device is inclined proximally and the distal portion of the porous structure is folded such that the distal facing end of the porous structure is directed towards the proximal end of the porous structure. Optionally, the anti-movement collar is any curved / atraumatic structure located about the distal end circumference of the porous structure.

Optionally, the external catheter includes a radiopaque marker at its distal end for radiographic visualization during delivery.

Optionally, the delivery device comprises a first handle attached to the proximal end of the inner catheter and having a lumen configured to slidably receive the proximal end, distal end and the guide wire; A second handle attached to the proximal end of the outer catheter and having a lumen configured to slidably receive the proximal end, distal end and the inner catheter, positioned between the first and second handles prior to delivery of the intragastric device A proximal portion of the inner catheter that is distracted and not covered by the outer catheter; An elongate flexible pilot component having a proximal end, a distal end, and a length having variable stiffness, wherein the pilot component includes a distal spherical component and a proximal spherical component and extends from the distal end of the inner catheter An elongate flexible pilot component; A first stop mechanism removably attached to the exposed portion of the inner catheter; And a second stop mechanism positioned proximate to the first stop mechanism and removably attached to the exposed portion of the inner catheter; The first and second stop mechanisms are configured to be sequentially removed from the inner catheter when the outer catheter is retracted.

The delivery device may further comprise a hydrophilic coating on at least one of the distal end and the pilot component of the outer catheter, upon activation the hydrophilic coating is configured to facilitate insertion and manipulation of the delivery device.

The delivery device may further comprise a port on at least one of the first handle for injecting fluid into the lumen of the inner catheter and at least one of the second handle for injecting fluid into the lumen of the outer catheter. .

Optionally, the proximal spherical component is configured to be atraumatic and includes a radiopaque marker for radiographic visualization during delivery, and the distal component is configured in an atraumatic ball-tip shape.

Optionally, the variable stiffness of the pilot component is less than the stiffness of the distal end of the outer catheter at its proximal end and is similar to the stiffness of the 0.035 inch guide wire at its distal end.

Optionally, said first and second stop mechanisms comprise plastic rings secured to said inner catheter using wing nuts.

The present disclosure also discloses a method of delivering a gastrointestinal device into a gastrointestinal tract of a patient using a delivery device, wherein the gastrointestinal device is a configurable porous structure between the compressed pre-deployed form and the expanded post-deployed form, the distal portion of the porous structure. An elongate sleeve coupled to the distal end of the porous structure and an anti-movement collar adjacent an end, the delivery device comprising: a flexible outer catheter having a proximal end, a distal end, and a lumen; A flexible inner catheter having a proximal end, a distal end, and a lumen configured to slidably receive the guide wire, wherein the inner catheter is coaxially positioned and configured to be slidably moveable within the lumen of the outer catheter; A first handle attached to the proximal end of the inner catheter and having a lumen configured to slidably receive the proximal end, distal end and the guide wire; A second handle attached to the proximal end of the outer catheter and having a proximal end, a distal end, and a lumen configured to slidably receive the inner catheter, a first stop removably attached to an exposed portion of the inner catheter Instrument; And a second stop mechanism positioned proximate to the first stop mechanism and removably attached to the exposed portion of the inner catheter, the method comprising: delivering the over the guide wire and into the gastrointestinal tract of the patient. Sliding the device; Using fluoroscopy to determine the position of the distal end of the flexible outer catheter to ensure accurate positioning of the delivery device; Holding the first handle to hold the inner catheter in place and retracting the outer catheter to the first stop mechanism; Retracting the entire delivery device until the distal end of the outer catheter is positioned near the pylorus of the patient; Removing the first stop mechanism from the internal catheter; Retaining the first handle to hold the inner catheter in place and retracting the outer catheter to the second stop mechanism; Removing the second stop mechanism; Retaining the first handle to hold the inner catheter in place and retracting the outer catheter to the first handle; And removing the delivery device from the patient.

Optionally, when the outer catheter is retracted to the first stop mechanism, a portion of the sleeve is delivered to and positioned inside the intestinal portion of the patient's gastrointestinal tract.

Optionally, when the outer catheter is retracted to the second stop mechanism, a portion of the sleeve and a portion of the porous structure is delivered to and located inside the gastrointestinal tract of the patient's gastrointestinal tract.

Optionally, when the catheter is retracted to the first handle, all of the porous structure is delivered to and located inside the gastrointestinal tract of the patient.

Optionally, the anti-movement collar of the gastrointestinal tract device is inclined proximally and the distal portion of the porous structure is folded such that the distal facing end of the porous structure is directed towards the proximal end of the porous structure. Optionally, the anti-movement collar is any curved / atraumatic structure located about the distal end circumference of the porous structure.

Prior to delivery of the intragastric device, the proximal portion of the inner catheter located between the first and second handles is exposed and not covered by the outer catheter.

Optionally, the delivery device further comprises an elongate flexible pilot component having a distal spherical component and a proximal spherical component and extending from the distal end of the inner catheter.

At least one of the distal end and the pilot component of the outer catheter may comprise a hydrophilic coating, the method further comprising activating the hydrophilic coating prior to sliding the delivery device over the guide wire Can be.

The present disclosure also discloses a delivery system for delivering a gastrointestinal device into a gastrointestinal tract of a patient, the system comprising a porous structure configurable between a compressed pre-deployed form and an expanded post-deployed form; A movement preventing collar adjacent the distal end of the porous structure; And an elongated sleeve coupled to the distal end of the porous structure; Delivery Device The delivery device comprises a flexible outer catheter having a proximal end, a distal end, and a lumen; A flexible inner catheter having a lumen configured to slidably receive a proximal end, a distal end, and a guide wire, wherein the inner catheter is coaxially positioned and configured to be slidably moveable within the lumen of the outer catheter; ; A first handle attached to the proximal end of the inner catheter and having a lumen configured to slidably receive the proximal end, distal end and the guide wire; A second handle attached to the proximal end of the outer catheter and having a lumen configured to slidably receive the proximal end, distal end and the inner catheter, the proximal portion of the inner catheter positioned between the first and second handles Not fully covered by the external catheter; An elongate flexible component comprising a distal spherical component and a proximal spherical component and extending from the distal end of the inner catheter; A first stop mechanism removably attached to the exposed portion of the inner catheter; A second stop mechanism positioned proximate to the first stop mechanism and removably attached to the exposed portion of the inner catheter; The distal end of the inner catheter is configured to pass through the opening of the porous structure, the sleeve is wound coaxially around the inner catheter, and the outer catheter proximal above the inner catheter while holding the inner catheter in place Can be retracted in a direction, and the first and second stop mechanisms are configured to be sequentially removed from the inner catheter when the outer catheter is retracted to expose and deliver a gastrointestinal device from the distal end of the delivery device. do.

The delivery system may further comprise a hydrophilic coating on at least one of the distal end of the outer catheter and the elongate flexible component, wherein when the hydrophilic coating is activated, the hydrophilic coating facilitates insertion and manipulation of the delivery device. Let's do it.

The delivery system of claim further comprises a port on at least one of the first handle for injecting fluid into the lumen of the inner catheter and at least one of the second handle for injecting fluid into the lumen of the outer catheter. Can be.

Optionally, the delivery device has a variable stiffness along its length.

Optionally, the anti-movement collar of the gastrointestinal tract device is inclined proximally and the distal portion of the porous structure is folded such that the distal facing end of the porous structure is directed towards the proximal end of the porous structure. Optionally, the anti-movement collar is any curved / atraumatic structure located about the distal end circumference of the porous structure.

The present disclosure also discloses a delivery device for endoscopy delivery of the gastrointestinal device into the gastrointestinal tract of a patient, wherein the gastrointestinal device is configurable between the compressed pre-deployed and expanded post-deployed forms and the distal end of the porous structure. An elongate sleeve coupled; said delivery device comprising: an elongate body having a proximal end and a distal end; And a restraint mechanism for restraining the device in the predeployment form coaxially over the distal end of the elongate body.

In one embodiment, the delivery device further comprises a locking mechanism for locking the delivery device at a particular location.

In one embodiment, the distal end comprises a distal portion and a proximal distal portion, wherein the distal portion is more flexible than the proximal distal portion.

In one embodiment, the transfer device further comprises a thread pull port on the proximal end, and the restraint mechanism includes a thread wound around the device in the predeployment form.

In one embodiment, the restraint mechanism includes a zippered sheath that coaxially covers the device in the predeployment form. In another embodiment, the restraint mechanism includes a detachable removal enclosure that coaxially covers the device in the predeployment form. In another embodiment, the restraint mechanism includes a tear removal enclosure that coaxially covers the device in the predeployment form.

The delivery device may include a proximal end, a distal end, and a dissociation removal enclosure that slides coaxially over the intragastric device for constraining the gastric device in the pre-deployed form coaxially over the distal end of the body of the delivery device. And the method of delivering the intragastric device comprises coaxially placing the confined intragastric device in the pre-deployed form over the distal end of the body of the delivery device; Inserting the delivery device into the patient and advancing the distal end of the body of the delivery device to the duodenum or jejunum of the patient; Once the gastrointestinal device is positioned, the work tool can be automatically inflated to the post-deployment form by removing the sheath from the confined intragastric device using a work tool to pull the sheath coaxially apart. step; And coaxially sliding the distal end of the body of the delivery device away from the expanded intragastric device and removing the delivery device from the patient.

Optionally, the method further comprises applying a cooling element to the compressed intragastric device to promote removal of the delivery device by slowing the expansion of the porous structure during removal of the sheath.

The present disclosure also discloses a retrieval device for endoscopic removal of an gastrointestinal device from a gastrointestinal tract of a patient, the gastrointestinal device comprising a porous structure configurable between a compressed pre-deployed form and an expanded post-deployed form, the periphery of the porous structure At least one circumferential constrainment mechanism located at and a proximal end recovery mechanism and an elongated sleeve coupled to the distal end of the porous structure, the recovery device having three proximal ends and a distal end and an lumen therein; Long body; An elongate metal wire disposed in said lumen and having a proximal end and a distal end; A gripping mechanism formed from the distal end of the wire for gripping the recovery end of the porous structure and the free end of the at least one circumferential constraining mechanism; And an actuator attached to the proximal end of the wire.

Optionally, the retrieval device further comprises a handle at the proximal end of the elongate body.

Optionally, the actuator is seated in the handle.

In one embodiment, the retrieval device comprises a gripper having two opposing jaws attached to the distal end of the elongated body and operatively connected to the actuator at the proximal end of the wire, And at least one clamp positioned between the jaws, wherein the jaws are configured to compress the clamp around the free end of the at least one circumferential bond mechanism.

The present disclosure also discloses a method of delivering an intragastric device into a gastrointestinal tract of a patient using a delivery device, wherein the intragastric device is configurable between a compressed pre-deployed form and an expanded post-deployed form and distal of the porous structure. An elongate sleeve coupled to the end, the method further comprising: deploying the porous structure without the sleeve in a first procedure and allowing the porous structure to expand into the post-deployment form; Deploying the sleeve within the expanded porous structure in a second procedure; And coupling the proximal end of the sleeve to the distal end of the porous structure during the second procedure.

Optionally, the method further comprises slowing the expansion of the porous structure during deployment by applying a cooling element to the compressed intragastric device during the first procedure.

Optionally, said first procedure is performed using a first catheter.

Optionally, said second procedure is performed using a second catheter.

The present disclosure also discloses a method for recovering a device from the gastrointestinal tract of a patient using a retrieval device, the device comprising a porous structure configurable between a compressed pre-deployed form and an expanded post-deployed form and comprising At least one circumferential constrainment mechanism located at and a proximal end recovery mechanism and an elongated sleeve coupled to the distal end of the porous structure, the recovery device having three proximal ends and a distal end and an lumen therein; An elongate metal wire disposed in the lumen and having a proximal end and a distal end, from the distal end of the wire for gripping the free end of the recovery mechanism and the at least one circumferential bond mechanism of the porous structure. The gripping mechanism formed and the proximal end of the wire Including an actuator attached to, and the method comprises the steps of inserting the endoscope into the patient to the collecting device and advancing the distal end of the body of the collection device to the proximal end of the device; Operating the gripping mechanism of the retrieval device to engage the free end of the at least one circumferential constraining mechanism located around the porous structure; Pulling the actuator of the retrieval device to compress the porous structure to the pre-deployed form by constraining and automatically locking the at least one circumferential bond mechanism; Operating the gripping mechanism of the retrieval device to separate the free end of the at least one circumferential binding mechanism; Operating the gripping mechanism to couple the recovery mechanism to the proximal end of the porous structure; Pulling the actuator to draw a proximal portion of the device into the lumen of the retrieval device; And removing the retrieval device and the device from the patient.

The intragastric device may comprise three circumferential restraint mechanisms positioned around the porous structure, the method comprising sequential manipulation of the gripping mechanism of the recovery device to engage the free ends of each of the three circumferential restraint mechanisms. step; And pulling the actuator of the retrieval device to fully compress the porous structure to the pre-deployed form by constraining and automatically locking the three circumferential constraining mechanisms.

In one embodiment, the method further comprises applying a cooling element to the compressed device to prevent re-expansion of the porous structure during removal of the device and the recovery device.

A retrieval device is at least positioned between the jaws of the gripper and the gripper having two opposing jaws attached to the distal end of the elongated body and operatively connected to the actuator at the proximal end of the wire. And may further comprise one clamp, the method manipulates the gripper of the retrieval device to apply the at least one clamp to the free end of the at least one circumferential constrainment mechanism adjacent the compressed porous structure. It may further comprise the step.

The present disclosure also discloses a retrieval device for endoscopy removal of the gastrointestinal device from a patient's gastrointestinal tract, the gastrointestinal device being configurable between the compressed pre-deployed and expanded post-deployed forms and at the distal end of the porous structure. An associated elongate sleeve, the retrieval device comprising: a flexible catheter having a proximal end, a distal end, and an internal lumen; An elongate wire located in the lumen of the catheter and having a proximal end and a distal end, wherein a portion of the distal end of the wire is formed by a gripping mechanism; A handle located at the proximal end of the catheter; And an elongated body having a proximal end and a distal end and a first lumen therein, wherein the tube is coaxially positioned above the catheter, the gripping mechanism is configured to grip the porous structure, and the elongate tube is And configured to receive the porous structure at its distal end.

The handle can include first and second handle components, the first and second handle components being separated to allow sliding of the elongate tube onto or from the catheter. Optionally, the first and second handle components are assembled and held together using screws.

The elongate tube may further include an adapter at its proximal end, wherein the adapter is configured to attach to the second handle component.

Optionally, the elongate tube further comprises: an inflatable balloon positioned at the distal end of the elongate tube; A vent port located at the proximal end of the elongate tube; A separate second lumen in fluid communication with the inflatable balloon and the vent port; And a compartment located at the distal end of the elongate tube configured to receive the balloon when the balloon is retracted, wherein the balloon is inflatable through the vent port and the second lumen, the balloon Is used to assist the compression of the porous structure into its predeployed form upon expansion.

Optionally, the elongate tube further includes a drip port at its proximal end for drip of cold fluid into the first lumen of the elongated tube, wherein the porous structure is comprised of a temperature sensitive material and the cold Fluid is used to assist in compressing the porous structure into its predeployed form.

The catheter may further include a sheath for restraining the gripping mechanism.

Optionally, the gripping mechanism includes a hook.

The present disclosure also discloses a method of recovering an intragastric device from a gastrointestinal tract of a patient using a retrieval device, the intragastric device comprising a porous structure configurable between a compressed pre-deployed form and an expanded post-deployed form and the porous structure An elongate sleeve coupled to the distal end of the retractable device, wherein the retrieval device is a flexible catheter having a proximal end, a distal end and an internal lumen, an elongated wire positioned within the lumen of the catheter and having a proximal end and distal end A portion of the distal end of the wire is formed with a gripping mechanism, the elongate tube having a handle located at the proximal end of the catheter and a proximal end, a distal end and a first lumen therein, the tube being Positioned coaxially over the catheter, the method being inserted into the patient Inserting the catheter into the working channel; Positioning the distal end of the endoscope in the stomach of the patient adjacent to the gastric device; Manipulating the elongate wire to extend the gripping mechanism beyond the distal end of the catheter, and gripping the porous structure with the gripping mechanism; Removing the handle from the catheter; Sliding the elongate tube over the catheter; Replacing the handle; Pulling the elongate wire to pull the porous structure into the elongate tube; And removing the retrieval device with the intragastric device from the patient.

The elongate tube may be in fluid communication with an inflatable balloon located at the distal end of the elongate tube, a drop injection port located at the proximal end of the elongate tube, the inflatable balloon and the drop injection port in fluid communication. A second lumen and a compartment located at the distal end of the elongate tube configured to receive the balloon when the balloon is retracted, the method further comprising: via the infusion port and the second lumen Inflating the balloon, wherein the expanded balloon extends from the compartment and is used to assist compression of the porous structure into its predeployed form.

Optionally, the elongate tube further comprises a drip port at its proximal end for the infusion of cold fluid into the first lumen of the elongate tube, the porous structure comprised of a temperature sensitive material, and the method Further comprises injecting a cryogenic fluid into the first lumen to assist compression of the porous structure into its predeployed form.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. Enter and pass through the interior and exit the porous structure through the at least one second opening, the porous structure having a substantially spherical post-development shape and having a first plurality of nodes at the top, a second plurality of bottoms Mesh comprising three nodes and a third plurality of nodes located in a lateral position between the top and the bottom A node includes a single unsupported free end or curve in the wire of the wire mesh; And a collar located at the bottom of the porous structure, the collar having a bent portion, the bent portion bent in a direction away from a longitudinal central axis of the porous structure and then bent upwards towards the porous structure. An extension of said wire being made; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is connected to the second plurality of nodes of the porous structure. By being combined, food leaving the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and leaves the sleeve through the fourth opening.

Optionally, the proximal end of the sleeve is coupled to the collar.

Each of the plurality of nodes may include 10 to 100 individual nodes. Optionally, each of said plurality of nodes comprises 44 nodes. Optionally, each of said plurality of nodes comprises 36 nodes.

The porous structure has a length, and the porous structure may include 2 to 60 plurality of nodes distributed in latitude directions at different positions along the length. At least 10% of the total number of nodes of the porous structure may be located at the top and the bottom. Optionally, up to 75% of the total number of nodes is located in any one of the plurality of nodes.

The wire mesh may be composed of shape memory metal.

The wire has a wire thickness, the bend of the collar has a bend radius, and the bend is twice the thickness when the collar is folded in the distal direction as the porous structure is compressed into the predeployment form. It can be defined as the bending strain divided by and multiplied by 100. Optionally, the flexural strain is in the range of 0.1-20%. Optionally, the flexural strain is 8% or less.

Optionally, the thickness is in the range of 0.1 to 1 mm. Optionally, the bend radius is in the range of 0.013 to 20 cm.

The thickness and bend radius can be configured to be less than the radius of the thickness, the radius being less than 2000 times the thickness.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. Enter and pass through the interior and exit the porous structure through the at least one second opening, the porous structure having a substantially spherical post-development shape and having a first plurality of nodes at the top, a second plurality of bottoms Mesh comprising three nodes and a third plurality of nodes located in a lateral position between the top and the bottom A node includes a single unsupported free end or curve in the wire of the wire mesh; And a collar located at the bottom of the porous structure, the collar having a bent portion, the bent portion bent in a direction away from a longitudinal central axis of the porous structure and then bent upwards towards the porous structure. An extension of the wire, wherein the wire has a wire thickness, the bend of the collar has a bend radius, and the bend is folded in the distal direction as the porous structure is compressed in its predeployment form. When defined by the bending strain divided by twice the thickness by the radius and multiplied by 100, the bending strain being in the range of 0.1 to 20%; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is connected to the second plurality of nodes of the porous structure. By being combined, food leaving the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and leaves the sleeve through the fourth opening.

Optionally, the flexural strain is 8% or less. Optionally, the thickness is in the range of 0.1 to 1 mm. Optionally, the bend radius is in the range of 0.013 to 20 cm.

The thickness and bend radius can be configured to be less than the radius of the thickness, the radius being less than 2000 times the thickness.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. Enter and pass through the interior and exit the porous structure through the at least one second opening, the porous structure having a substantially spherical post-development shape and having a first plurality of nodes at the top, a second plurality of bottoms Mesh comprising three nodes and a third plurality of nodes located in a lateral position between the top and the bottom A node comprises a single unsupported free end or curve in the wire of the wire mesh, each of the plurality of nodes comprising up to 44 individual nodes; And a collar located at the bottom of the porous structure, the collar having a bent portion, the bent portion bent in a direction away from a longitudinal central axis of the porous structure and then bent upwards towards the porous structure. An extension of the wire, wherein the wire has a wire thickness, the bend of the collar has a bend radius, and the bend is folded in the distal direction as the porous structure is compressed in its predeployment form. When defined by the bending strain divided by twice the thickness by the radius and multiplied by 100, wherein the bending strain ranges from 0.1 to 20%; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is connected to the second plurality of nodes of the porous structure. By being combined, food leaving the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and leaves the sleeve through the fourth opening.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. Enter, pass through the interior, and exit the porous structure through the at least one second opening; And a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, the pre-development shape having a first length and a deployment having a second length greater than the first length. And a proximal end of the sleeve, wherein the proximal end of the sleeve enters the sleeve through the third opening through the third opening and the food exiting the at least one second opening when the sleeve is in the post-deployed form; Coupled to the bottom of the porous structure to pass through and exit the sleeve through the fourth opening, wherein the sleeve is configured to provide a support to the sleeve when in the post-deployment form. Further comprising at least one spiral wire extending along the thickness of the wire and the pitch of the wire. Further has a strain to be defined, the pitch is defined by the distance between any two points in accordance with the wire disposed in the same plane along the longitudinal axis of the sleeve.

The helical wire may be composed of shape memory metal. Optionally, the shape memory metal is nitinol.

The helical wire may have a strain in the range of 0.1-20% when compressed as the sleeve is compressed and folded into its predeployed form. Optionally, the helical wire has a strain of 8% or less when compressed as the sleeve is compressed and folded into its predeployed form. The pitch can range from 5 to 150 mm. Optionally, the pitch is equal to 60 mm.

The sleeve may have a length in the range of 1 cm to 120 cm and may be configured to traumatically pass into and out of the pylorus of the patient.

The sleeve may be substantially funnel shaped and has a diameter that decreases as the sleeve extends from the proximal end to the distal end.

Optionally, the proximal portion of the sleeve is funneled, and the proximal end of the sleeve has a diameter greater than the diameter along any other portion of the sleeve body, the proximal end diameter extending in the distal direction of the sleeve body. Gradually decrease.

Optionally, the distal portion of the sleeve body includes two or more layers configured to reinforce the distal portion and to maintain the sleeve body in an elongate shape when in the post-deployment form.

Optionally, the sleeve comprises a proximal portion and a distal portion, the proximal portion extending from the proximal end of the sleeve to a transition point on the sleeve body, wherein the distal portion from the transition point to the distal end of the sleeve. And the proximal portion is funnel shaped and has a diameter that decreases as the proximal portion extends from the proximal end of the sleeve to the transition point. Also optionally, the distal portion is funnel shaped and has a diameter that decreases as the distal portion extends from the transition point to the distal end of the sleeve. Alternatively, the distal portion is cylindrical in shape and has a diameter that remains constant as the distal portion extends from the transition point to the distal end of the sleeve. Optionally, the diameter of the distal portion increases as the distal portion extends from the transition point to the distal end of the sleeve.

The sleeve may be comprised of at least one layer of any one or combination of polytetrafluoroethylene (PTFE), polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE) and ultra high molecular weight polyethylene (UHMWPE). . Optionally, the sleeve comprises at least two layers of any one or combination of polytetrafluoroethylene (PTFE), polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE) and ultra high molecular weight polyethylene (UHMWPE). And further, at least one metal wire support positioned between the layers.

Optionally, the intragastric device further comprises a component configured to attach to the distal end of the sleeve such that the distal end is non-traumatic with respect to body tissue, the component comprising a cylindrical body, a proximal end, a distal end and an interior. A lumen, wherein the component is open at both ends, the lumen of the component is in fluid communication with the interior of the sleeve, and further the outer surface of the component comprises a groove and a circular member located within the groove. And the component is attached to the sleeve by positioning a portion of the sleeve in the groove and below the circular member.

Optionally, said component further comprises a flange extending from said outer surface, said flange covering a free end of said distal end of said sleeve. Alternatively, the component further includes a heat shrink tube located above the circular member and the groove. Also optionally, the distal end of the sleeve is folded under the circular member, so that the free end of the distal end of the sleeve is located within the sleeve.

Optionally, the intragastric device further comprises at least one tail extending from the distal end of the sleeve, the tail configured to pull the sleeve in the distal direction to assist proper orientation of the sleeve within the gastrointestinal tract of the patient. .

The distal portion of the sleeve may further comprise a plurality of sleeve perimeters, wherein the periphery is attached to the member at the distal end of the sleeve, and further the member is adapted to assist proper orientation of the sleeve within the gastrointestinal tract of the patient. And to pull the sleeve in the distal direction. Optionally, the perimeter and distal member are parachute shaped.

The distal end of the sleeve may include a plurality of sutures, each having a proximal end and a distal end, wherein the proximal end of the suture is attached to the distal end of the sleeve, and the distal end of the suture is a gastrointestinal tract of the patient. A member configured to pull the sleeve in the distal direction to assist in proper orientation of the sleeve within. Optionally, the perimeter and distal member are parachute shaped.

The distal end of the sleeve may comprise a plurality of sutures each having a proximal end and a distal end, the proximal end of the suture is attached to the distal end of the sleeve, and the distal end of the suture is in a separate member. Each attached, each individual member is configured to pull the sleeve in the distal direction to assist in proper orientation of the sleeve within the patient's gastrointestinal tract.

Optionally, the sleeve is folded around itself at least once along the longitudinal axis of the sleeve to provide the sleeve with additional structure.

The sleeve may comprise at least one channel extending along the longitudinal axis of the sleeve, the at least one channel receiving a support member to provide the sleeve with an additional structure.

At least a portion of the sleeve may have a corrugated structure composed of alternating grooves and ridges to provide the sleeve with additional structure.

At least a portion of the sleeve may comprise a flexible wire composed of a structure knitted to provide the sleeve with additional structure.

The sleeve may comprise at least one channel extending along the longitudinal axis of the sleeve, wherein the at least one channel is configured to receive the fluid to provide the sleeve with an additional structure.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. Enter, pass through the interior, and exit the porous structure through the at least one second opening; And a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, the pre-development shape having a first length and a deployment having a second length greater than the first length. And a proximal end of the sleeve, wherein the proximal end of the sleeve enters the sleeve through the third opening through the third opening and the food exiting the at least one second opening when the sleeve is in the post-deployed form; Coupled to the bottom of the porous structure to pass through and exit the sleeve through the fourth opening, wherein the sleeve is configured to provide a support to the sleeve when in the post-deployment form. And further comprising three spiral wires extending along each of said spiral wires, said each of said spiral wires having a thickness of said individual wires and It has an individual strain defined by an individual pitch, and further said individual pitch is defined by the distance between any two points along the individual wires disposed in the same plane along the longitudinal axis of the sleeve.

Each of the spiral wires may be composed of a shape memory metal. Optionally, the shape memory metal is nitinol.

Each of the helical wires may have a strain in the range of 0.1 to 20% when compressed as the sleeve is compressed and folded into its predeployed form. Optionally, each of the helical wires has a strain of 8% or less when compressed as the sleeve is compressed and folded into its predeployed form.

The individual pitch of each of the helical wires may range from 5 to 150 mm.

Optionally, the individual pitch of each of the helical wires is equal to 60 mm.

Optionally, each of the wires comprises an adjacent wire pitch defined as a distance between any two points along two adjacent wires disposed in the same plane along the longitudinal axis of the sleeve, the adjacent wire pitch being 20 mm and same.

Optionally, the proximal portion of the sleeve is funneled, and the proximal end of the sleeve has a diameter greater than the diameter along any other portion of the sleeve body, the proximal end diameter extending in the distal direction of the sleeve body. Gradually decrease.

Optionally, the distal portion of the sleeve body includes two or more layers configured to reinforce the distal portion and to maintain the sleeve body in an elongate shape when in the post-deployment form.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. Enter, pass through the interior, and exit the porous structure through the at least one second opening; And a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, the pre-development shape having a first length and a deployment having a second length greater than the first length. And a proximal end of the sleeve, wherein the proximal end of the sleeve enters the sleeve through the third opening through the third opening and the food exiting the at least one second opening when the sleeve is in the post-deployed form; Coupled to the bottom of the porous structure to pass through and exit the sleeve through the fourth opening, wherein the sleeve is configured to provide a support to the sleeve when in the post-deployment form. Further comprising at least one spiral wire extending along the thickness of the wire and the pitch of the wire. Having a strain defined by the solution, the sleeve can be folded on itself at least five times so that the strain does not exceed 20%, and further the pitch is arranged in the same plane along the longitudinal axis of the sleeve It is defined by the distance between any two points along.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. Enter and pass through the interior and exit the porous structure through the at least one second opening, the porous structure having a substantially spherical post-development shape and having a first plurality of nodes at the top, a second plurality of bottoms Mesh comprising three nodes and a third plurality of nodes located in a lateral position between the top and the bottom A node includes a single unsupported free end or curve in the wire of the wire mesh; And a collar located at the bottom of the porous structure, the collar having a bent portion, the bent portion bent in a direction away from a longitudinal central axis of the porous structure and then bent upwards towards the porous structure. An extension of said wire being made; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is connected to the second plurality of nodes of the porous structure. The food leaving the at least one second opening enters the sleeve through the third opening, passes through the sleeve, leaves the sleeve through the fourth opening, and At least a portion of the total number of nodes is coupled to the proximal end of the sleeve by sutures.

Each node of the portion of the total number of nodes of the second plurality of nodes may be sealed to the proximal end of the sleeve at the most distal position on each node. Optionally, the portion of the total number of nodes of the second plurality of nodes includes all of the nodes in the second plurality of nodes. Optionally, the portion of the total number of nodes of the second plurality of nodes includes all other nodes in the second plurality of nodes.

The seal can be loosely applied to allow some relative movement between the wire mesh and the sleeve.

Each suture coupling the sleeve to each of the nodes of the portion of the total number of nodes of the second plurality of nodes may comprise only one knot.

The wire of the wire mesh may comprise at least two ends, which ends are joined and crimped together using a metal tube.

The wire of the wire mesh may include at least two ends, which ends are looped back onto the wire to create an atraumatic wire end or outwardly looped to create an attachment point to the sleeve.

The sleeve can include a wire for support, the wire can include at least two ends, the ends looped back onto the wire to create an atraumatic wire end, or It is looped outwardly to create an attachment point for engagement, or used to pull the sleeve during compression of the device.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. Enter and pass through the interior and exit the porous structure through the at least one second opening, the porous structure having a substantially spherical post-development shape and having a first plurality of nodes at the top, a second plurality of bottoms Mesh comprising three nodes and a third plurality of nodes located in a lateral position between the top and the bottom A node includes a single unsupported free end or curve in the wire of the wire mesh; And a collar located at the bottom of the porous structure, the collar having a bent portion, the bent portion bent in a direction away from a longitudinal central axis of the porous structure and then bent upwards towards the porous structure. An extension of said wire being made; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is connected to the second plurality of nodes of the porous structure. The combined food leaving the at least one second opening enters the sleeve through the third opening, passes through the sleeve, leaves the sleeve through the fourth opening, and the wire proximate each node. A portion of the intersects another portion of the wire proximal to the adjacent node to create an intersection, and at least a portion of the total number of the intersections at the bottom of the porous structure is coupled to the proximal end of the sleeve by a seal.

Optionally, the portion of said total number of said intersections of said bottoms of said porous structure comprises all of said intersections adjacent said bottoms of said porous structures. Optionally, the portion of said total number of said intersections of said bottom of said porous structure comprises all other intersections adjacent said bottom of said porous structure.

The seal can be loosely applied to allow some relative movement between the wire mesh and the sleeve.

Each suture coupling the sleeve to each of the intersections of the portion of the total number of intersections adjacent the bottom of the porous structure may comprise only one knot.

The wire of the wire mesh may comprise at least two ends, which ends are joined and crimped together using a metal tube.

The wire of the wire mesh may include at least two ends, which ends are looped back onto the wire to create an atraumatic wire end or outwardly looped to create an attachment point to the sleeve.

The sleeve can include a wire for support, the wire can include at least two ends, the ends looped back onto the wire to create an atraumatic wire end, or It is looped outwardly to create an attachment point for engagement, or used to pull the sleeve during compression of the device.

The present disclosure also discloses a method for compressing an intragastric device for loading onto a delivery device prior to deployment, the intragastric device comprising a top, a bottom and an interior, the predeployment form having a first volume and the first A porous structure comprising a post-development form having a second volume greater than the volume, wherein in the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom. Whereby food enters the porous structure through the at least one first opening, passes through the interior, leaves the porous structure through the at least one second opening, and the porous structure is in a substantially spherical post-development form. Having a first plurality of nodes at the top, a second plurality of nodes at the bottom, and the top and the bottom The lateral position of the wire mesh 3 includes a plurality of node positions in between - that each node comprises a single unsupported free end or bend the wires of the wire mesh; And a collar located at the bottom of the porous structure, the collar having a bent portion, the bent portion bent in a direction away from a longitudinal central axis of the porous structure and then bent upwards towards the porous structure. An extension of said wire being made; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is connected to the second plurality of nodes of the porous structure. The food leaving the at least one second opening enters the sleeve through the third opening, passes through the sleeve, leaves the sleeve through the fourth opening, and At least a portion of the total number of nodes is coupled to the proximal end of the sleeve by sutures, the method comprising compressing the wire mesh around a longitudinal central axis of the porous structure; And pulling the distal end of the sleeve such that the curved portion of the collar bends in a downward direction to bend downward so that the collar is substantially straightened.

The seal can be loosely applied to allow some relative movement between the wire mesh and the sleeve.

The sleeve can include a wire for support, the wire can include at least two ends, the ends looped back onto the wire to create an atraumatic wire end, or It is looped outwardly to create an attachment point for engagement, or used to pull the sleeve during compression of the device.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. Enter, pass through the interior, and exit the porous structure through the at least one second opening; And a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, the pre-development shape having a first length and a deployment having a second length greater than the first length. And a proximal end of the sleeve, wherein the proximal end of the sleeve enters the sleeve through the third opening through the third opening and the food exiting the at least one second opening when the sleeve is in the post-deployed form; Coupled to the bottom of the porous structure to pass through the interior and exit the sleeve through the fourth opening, the sleeve being folded over at least on its own, wound around a portion of the deployment device, and deployed While being pulled back and forth and having a coefficient of friction that allows for full deployment without any structural damage to the sleeve.

The coefficient of friction can range from 0.01 to 0.30. Optionally, the friction coefficient is 0.10 or less.

The sleeve has an outer surface, which may be a matte surface. Particulate material can be applied to the outer surface of the sleeve. Optionally, the particulate material is corn starch. Optionally, the particulate material is a biocompatible powder.

The sleeve may itself be folded at least twice.

The present disclosure also discloses a method of delivering an intragastric device to the gastrointestinal tract of a patient, the gastrointestinal device comprising a top, bottom and interior, having a pre-development form having a first volume and having a second volume greater than the first volume. A porous structure comprising a post-deployment form, wherein in the post-deployment form, the porous structure includes at least one first opening adjacent to the top and at least one second opening adjacent to the bottom such that food is formed in the at least one Enter the porous structure through a first opening, pass through the interior, and leave the porous structure through the at least one second opening— and a flexible elongated body, a proximal end with a third opening, a fourth Having a distal end with an opening and a sleeve interior, the predeployment form having a first length and the postdeployment type having a second length greater than the first length And a proximal end of the sleeve wherein food leaving the at least one second opening enters the sleeve through the third opening when the sleeve is in the post-deployment form, Pass through and engage the bottom of the porous structure through the fourth opening to exit the sleeve, the sleeve being folded over at least on itself, wound around a portion of the deployment device, and back and forth during deployment. Having a coefficient of friction that is towed and can be fully deployed without any structural damage to the sleeve, the method comprising: loading the porous structure onto a delivery device; Folding the sleeve on itself; Winding the folded sleeve around a portion of the delivery device; Inserting the delivery device comprising the porous structure and the sleeve into the gastrointestinal tract of the patient; Manipulating the delivery device to fully deploy the sleeve; Further manipulating the delivery device to fully deploy the porous structure; And removing the delivery device from the patient.

The coefficient of friction can range from 0.01 to 0.30.

The method may further comprise applying particulate material to the outer surface of the sleeve prior to folding the sleeve on itself. Optionally, the particulate material is corn starch. Optionally, the particulate material is a biocompatible powder.

The sleeve may itself be folded at least twice.

The present disclosure also discloses a method of delivering an intragastric device to the gastrointestinal tract of a patient, the gastrointestinal device comprising a top, bottom and interior, having a pre-development form having a first volume and having a second volume greater than the first volume. A porous structure comprising a post-deployment form, wherein in the post-deployment form, the porous structure includes at least one first opening adjacent to the top and at least one second opening adjacent to the bottom such that food is formed in the at least one Enter the porous structure through a first opening, pass through the interior, and leave the porous structure through the at least one second opening— and a flexible elongated body, a proximal end with a third opening, a fourth Having a distal end with an opening and a sleeve interior, the predeployment form having a first length and the postdeployment type having a second length greater than the first length And a proximal end of the sleeve wherein food leaving the at least one second opening enters the sleeve through the third opening when the sleeve is in the post-deployment form, Pass through and engage the bottom of the porous structure through the fourth opening to exit the sleeve, the sleeve being folded over at least on itself, wound around a portion of the deployment device, and back and forth during deployment. Having a coefficient of friction that is towed and can be fully deployed without any structural damage to the sleeve, the method comprising: loading the porous structure onto a delivery device; Folding the sleeve on itself; Winding the folded sleeve around a portion of the delivery device; Inserting the delivery device comprising the porous structure and the sleeve into the gastrointestinal tract of the patient; Manipulating the delivery device to partially deploy the sleeve, wherein the sleeve is completely released from the delivery device but only partially unfolded from the fold; Further manipulating the delivery device to fully deploy the porous structure; Removing the delivery device from the patient; And allowing the sleeve to fully unfold through the action of peristaltic contraction on the sleeve.

The coefficient of friction can range from 0.01 to 0.30.

The method may further comprise applying particulate material to the outer surface of the sleeve prior to folding the sleeve on itself. Optionally, the particulate material is corn starch. Optionally, the particulate material is a biocompatible powder.

The sleeve may itself be folded at least twice.

The present disclosure also discloses a delivery device for delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device coupled to the distal end of the porous structure and the porous structure configurable between the compressed pre-deployed and expanded post-deployed forms. An elongated sleeve, wherein the delivery device includes a flexible elongated body having a proximal end, a distal end, and an internal body lumen, the body including an opening in the distal end and a first handle attached to the proximal end. box-; A flexible plunger component positioned coaxially and longitudinally movable within the lumen of the body, the plunger comprising a proximal end, a distal end and an internal plunger lumen, attached to the tip of the distal end and the proximal end A second handle that is adapted; A flexible elongated rod positioned coaxially and longitudinally movable within the plunger lumen, the rod comprising a proximal end and a distal end, the first spherical component positioned proximate to the distal end and the distal end; A second spherical component positioned, said first spherical component having a diameter greater than the diameter of said second spherical component, said rod further comprising a third handle attached to said proximal end; And a traction mechanism comprising a first end and a second end, the first end attached to the sleeve of the intragastric device, the second end being the first spherical component and the second spherical component. Removably coupled to the rod at a position therebetween, the intragastric device is loaded for delivery in the delivery device, and the loading is such that the porous structure is positioned within the body lumen distal to the plunger tip and proximal to the sleeve. The rod passes through at least two openings in the porous structure, wherein the at least two openings are not disposed along a central longitudinal axis of the porous structure; The sleeve is located in the body lumen distal of the porous structure and proximal of the first spherical component, the sleeve is folded onto itself, and then wound around a portion of the rod, and further the A sleeve is attached to the first end of the traction mechanism.

The delivery device may further comprise a stopper positioned on the plunger between the tip and the second handle.

Optionally, the traction mechanism is biodegradable and includes a suture or hook. Alternatively, the traction mechanism is non-biodegradable and includes a suture having a loop end.

Optionally, the sleeve is bound by a ring, cone or umbrella shaped bondage device.

Optionally, said tip of said plunger comprises a mesh retaining component comprising a plurality of fins, said proximal portion of said porous structure moving said pin in said proximal direction when said plunger is moved in the proximal direction Positioned on the pin.

The sleeve may be folded two to ten times on itself before being wound on the rod.

The delivery device may further include an inflatable balloon at the distal end of the body, an input port at the proximal end of the body and a channel extending along the elongated body while in fluid communication with the balloon and the port, The balloon is inflated using the port and the channel, the inflated balloon being used to secure the delivery device within the gastrointestinal tract of the patient.

Optionally, the delivery device may further comprise a flushing or perfusion mechanism to dampen the deployment force during delivery.

The elongate body can include a length, and the length can include variable stiffness. Optionally, the length includes at least three zones, and the distal most zone is more flexible than the central distal zone, which is more flexible than the minimum distal zone.

The elongated body may comprise a braided catheter.

The distal ends of the elongate body, plunger and rod may be configured atraumatic. The present disclosure also discloses a delivery device for delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device coupled to the distal end of the porous structure and the porous structure configurable between the compressed pre-deployed and expanded post-deployed forms. An elongated sleeve, wherein the delivery device includes a flexible elongated body having a proximal end, a distal end, and an internal body lumen, wherein the body includes an opening in the distal end and an actuation mechanism attached to the proximal end. -; A flexible plunger component positioned coaxially and longitudinally movably within the lumen of the body, the plunger comprising a proximal end, a distal end and an internal plunger lumen, comprising a tip of the distal end, and the proximal end An end is operatively attached to the actuation mechanism; An actuator handle and an actuator trigger attached to the actuator and configured to actuate the actuator to move the plunger back and forth in the longitudinal direction relative to the elongate body during operation; A flexible elongated rod positioned coaxially and longitudinally movable within the plunger lumen, the rod comprising a proximal end and a distal end, the first spherical component positioned proximate to the distal end and the distal end; A second spherical component positioned, said first spherical component having a diameter greater than the diameter of said second spherical component, said rod further comprising a rod handle attached to said proximal end; And a traction mechanism comprising a first end and a second end, the first end attached to the sleeve of the intragastric device, the second end being the first spherical component and the second spherical component. Removably coupled to the rod at a position therebetween, the intragastric device is loaded for delivery in the delivery device, and the loading is such that the porous structure is positioned within the body lumen distal to the plunger tip and proximal to the sleeve. The rod passes through at least two openings in the porous structure, wherein the at least two openings are not disposed along a central longitudinal axis of the porous structure; The sleeve is located in the body lumen distal of the porous structure and proximal of the first spherical component, the sleeve is folded onto itself, and then wound around a portion of the rod, and further the A sleeve is attached to the first end of the traction mechanism.

The delivery device may further comprise a stopper positioned on the plunger between the tip and the actuation mechanism.

Optionally, the traction mechanism is biodegradable and includes a suture or hook. Alternatively, the traction mechanism is non-biodegradable and includes a suture having a loop end.

Optionally, the sleeve is bound by a ring, cone or umbrella shaped bondage device.

Optionally, said tip of said plunger comprises a mesh retaining component comprising a plurality of fins, said proximal portion of said porous structure moving said pin in said proximal direction when said plunger is moved in the proximal direction Positioned on the pin.

The sleeve may be folded two to ten times on itself before being wound on the rod.

The delivery device may further include an inflatable balloon at the distal end of the body, an input port at the proximal end of the body and a channel extending along the elongated body while in fluid communication with the balloon and the port, The balloon is inflated using the port and the channel, the inflated balloon being used to secure the delivery device within the gastrointestinal tract of the patient.

Optionally, the delivery device may further comprise a flushing or perfusion mechanism to dampen the deployment force during delivery.

The elongated body may comprise a braided catheter.

The present disclosure also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient, wherein the intragastric device is comprised of a configurable porous structure between the compressed pre-deployed form and the expanded post-deployed form and three distal ends coupled to the porous structure. An elongate sleeve, the delivery device having a flexible elongated body having a proximal end, a distal end, and an internal body lumen, the body including an opening in the distal end and a first handle attached to the proximal end; And a flexible plunger component positioned coaxially and longitudinally within the lumen of the body, the plunger comprising a proximal end, a distal end and an internal plunger lumen and attached to the tip of the distal end and the proximal end. A second handle configured to move coaxially and longitudinally within the plunger lumen A flexible elongated rod, the rod including a proximal end and a distal end, comprising a first spherical component located proximate the distal end and a second spherical component located at the distal end, the first The spherical component has a diameter greater than the diameter of the second spherical component, the rod further comprising a third handle attached to the proximal end— and a traction mechanism including a first end and a second end. And the first end is attached to the sleeve of the gastric device, the second end is removably coupled to the rod at a position between the first spherical component and the second spherical component, The device is loaded for delivery in the delivery device such that the porous structure is located in the body lumen distal to the plunger and proximal to the sleeve, A preload rod passes through at least two openings in the porous structure, wherein the at least two openings are not disposed along a central longitudinal axis of the porous structure, and the sleeve is distal to the first spherical component of the porous structure. Located within the body lumen proximal of the sleeve, the sleeve is folded onto itself, and then wound around a portion of the rod, and further the sleeve is attached to the first end of the traction mechanism; Sliding the delivery device over a guide wire into the gastrointestinal tract of the patient; Positioning the distal end of the elongated body in the duodenum of the patient using a first handle; Pushing a second handle to propel the plunger component until the sleeve is pushed out of the elongated body; Pushing a third handle to advance the rod in the plunger lumen until the sleeve is fully deployed; Retracting the delivery device to reposition the distal end of the elongated body within the stomach of the patient; Holding the second handle stationary to reversely pull the first handle and release the wire mesh structure while keeping the plunger in place; And removing the delivery device from the patient.

The delivery device may further comprise a stopper positioned on the plunger between the tip and the second handle, the stopper stopping further distal movement of the plunger after the sleeve is propelled out of the elongated body. It is configured to.

The delivery device may further include an inflatable balloon at the distal end of the body, an input port at the proximal end of the body and a channel extending along the elongated body while in fluid communication with the balloon and the port, The method may further comprise using the port and the channel to inflate the balloon to secure a delivery device within the gastrointestinal tract of the patient.

The present disclosure also discloses a delivery device for delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device coupled to the distal end of the porous structure and the porous structure configurable between the compressed pre-deployed and expanded post-deployed forms. An elongated sleeve, wherein the delivery device includes a flexible elongated body having a proximal end, a distal end, and an internal body lumen, the body including an opening in the distal end and a first handle attached to the proximal end. box-; A flexible elongated rod positioned coaxially and longitudinally movable within the body lumen, the rod including a proximal end and a distal end, the first spherical component positioned proximate to the distal end and the distal end; A second spherical component positioned, said first spherical component having a diameter greater than the diameter of said second spherical component, said rod further comprising a second handle attached to said proximal end; A flexible plunger component coaxially positioned over and prolonged with the proximal portion of the flexible elongated rod, the plunger comprising a proximal end and a distal end, comprising a tip of the distal end and the Attached to the second handle at a proximal end; And a traction mechanism comprising a first end and a second end, the first end attached to the sleeve of the intragastric device, the second end being the first spherical component and the second spherical component. Removably coupled to the rod at a position therebetween, the intragastric device is loaded for delivery in the delivery device, and the loading is such that the porous structure is positioned within the body lumen distal to the plunger tip and proximal to the sleeve. The rod passes through at least two openings in the porous structure, wherein the at least two openings are not disposed along a central longitudinal axis of the porous structure; The sleeve is located in the body lumen distal of the porous structure and proximal of the first spherical component, the sleeve is folded onto itself, and then wound around a portion of the rod, and further the A sleeve is attached to the first end of the traction mechanism.

The traction mechanism can be biodegradable and can include sutures or hooks. Alternatively, the traction mechanism is non-biodegradable and includes a suture having a loop end.

The sleeve may be bound by a ring, cone or umbrella shaped bondage device.

Optionally, said tip of said plunger comprises a mesh retaining component comprising a plurality of fins, said proximal portion of said porous structure moving said pin in said proximal direction when said plunger is moved in the proximal direction Positioned on the pin.

Optionally, the sleeve can be folded two to ten times on itself before being wound around the rod.

Optionally, the delivery device further comprises an inflatable balloon of the distal end of the body, an input port of the proximal end of the body and a channel extending along the elongated body and in fluid communication with the balloon and the port; And the balloon is inflated using the port and the channel, the inflated balloon being used to secure the delivery device within the gastrointestinal tract of the patient.

Optionally, the delivery device may further comprise a flushing or perfusion mechanism to dampen the deployment force during delivery.

The elongated body may comprise a length, the length comprising variable stiffness.

The elongate body may comprise at least three zones, with the distal most zone being more flexible than the central distal zone, which is more flexible than the minimum distal zone.

The elongated body may comprise a braided catheter.

The distal ends of the elongate body, plunger and rod may be configured atraumatic. The present disclosure also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient, wherein the intragastric device is comprised of a configurable porous structure between the compressed pre-deployed form and the expanded post-deployed form and three distal ends of the porous structure. An elongate sleeve, the delivery device having a flexible elongated body having a proximal end, a distal end, and an internal body lumen, the body including an opening in the distal end and a first handle attached to the proximal end; And a flexible elongated rod positioned coaxially and longitudinally within the lumen of the body, the rod including a proximal end and a distal end and positioned close to the distal end and the distal end. A second spherical component located at the first spherical component, the first spherical component having a diameter of the second spherical component; Having a larger diameter, the rod further comprises a second handle attached to the proximal end, wherein the flexible plunger configuration is coaxially positioned over the proximal portion of the flexible elongated rod and longitudinally movable therewith. An element—the plunger includes a proximal end and a distal end, includes a tip of the distal end and is attached to the second handle at the proximal end— and includes a traction mechanism including a first end and a second end; The first end is attached to the sleeve of the gastric device, the second end is removably coupled to the rod at a position between the first spherical component and the second spherical component, the intragastric device Is used for delivery within the delivery device such that the porous structure is located within the body lumen distal to the plunger and proximal to the sleeve. Wherein the rod passes through at least two openings in the porous structure, the at least two openings are not disposed along a central longitudinal axis of the porous structure, and the sleeve is distal and of the first spherical shape of the porous structure. Located in the body lumen proximal of the component, the sleeve is folded onto itself, and then wound around a portion of the rod, and further the sleeve is attached to the first end of the traction mechanism, The method includes sliding the delivery device over a guide wire into the gastrointestinal tract of the patient; Positioning the distal end of the elongated body in the duodenum of the patient using a first handle; Pushing the second handle to propel the plunger component and rod until the sleeve is fully deployed; Retracting the delivery device to reposition the distal end of the elongated body within the stomach of the patient; Holding the second handle stationary to reversely pull the first handle and release the wire mesh structure while keeping the plunger and rod in place; And removing the delivery device from the patient.

Optionally, said delivery device further comprises a stopper positioned on said plunger between said tip and said second handle, said stopper further adding said plunger and rod after said sleeve is propelled out of said elongated body. And to stop distal movement.

Optionally, the delivery device further comprises an inflatable balloon at the distal end of the body, an input port at the proximal end of the body and a channel extending along the elongated body and in fluid communication with the balloon and the port. And the method further comprises using the port and the channel to inflate the balloon to secure the delivery device in the gastrointestinal tract of the patient.

The present disclosure also discloses a delivery system for delivering an intragastric device, the delivery system comprising: an external catheter having proximal and distal ends and variable stiffness along its length; And a flexible inner catheter positioned coaxially inside the outer catheter and having a lumen for receiving the proximal end, the atraumatic distal end and the guiding device; The intragastric device is located in a space between an inner catheter and an outer catheter, the inner catheter including a flexible extension having a length of at least 5 cm at its distal end extending beyond the distal end of the outer catheter.

Optionally, the guiding device is a guide wire. Alternatively, the guidance device is an endoscope for over the scope delivery.

The atraumatic distal end may be a ball-tip.

The internal catheter may have a variable stiffness along its length.

Optionally, the flexible extension includes a proximal end and a distal end, and has varying stiffness along its length, the stiffness varying between the stiffness of the guide wire at the distal end and the stiffness of the internal catheter at the proximal end.

The present disclosure also discloses an intragastric device, wherein the intragastric device comprises a top, bottom, and interior, the porous structure comprising a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. In the post-deployment form, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food may pass through the at least one first opening to the porous structure. A wire mesh entering and passing through the interior and exiting the porous structure through the at least one second opening, the porous structure having a substantially spherical post-development shape; And a collar located at the bottom of the porous structure, the collar having a bent portion, the bent portion bent in a direction away from a longitudinal central axis of the porous structure and then bent upwards towards the porous structure. An extension of said wire being made; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the collar to thereby provide the at least one second. Food leaving the opening enters the sleeve through the third opening, passes through the sleeve, passes the sleeve through the fourth opening, and the sleeve intermittently engages with the patient's pylori without blocking the pylori. Designed and allows the passage of food from the stomach through the lumen of the sleeve to the small intestine.

The present disclosure also discloses a system for delivering an intragastric device to the gastrointestinal tract of a patient, the system comprising a porous mesh structure having a first lumen; A sleeve having a second lumen attached to the porous mesh structure; A coaxial catheter system comprising an outer catheter and an inner catheter, wherein prior to delivery, the porous mesh structure and the sleeve are bound within a space between the outer and inner catheter, the outer catheter covering a substantial portion of the intragastric device, The inner catheter passes inside most of the first lumen of the mesh but is outside of most of the second lumen of the sleeve.

Optionally, the inner catheter is operatively attached to the sleeve at the distal end of the inner catheter such that in operation the inner catheter pushes the sleeve out of the coaxial catheter system and then separates from the sleeve to deliver the intragastric device into the gastrointestinal tract.

The present disclosure also discloses a system for promoting weight loss of a patient, the system comprising an intragastric device, a delivery device and a retrieval device, the gastric device configured to be temporarily deployed within the gastrointestinal tract of the patient, the intragastric device A porous structure comprising a top, a bottom and an interior, wherein the porous structure comprises a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. At least one first opening adjacent to and at least one second opening adjacent to the bottom, whereby food enters the porous structure through the at least one first opening, passes through the interior, and the at least one Exit the porous structure through a second opening of the porous structure; A collar positioned at the bottom of the sieve, the collar having a bend, the bend being bent in a direction away from the longitudinal central axis of the porous structure and then the porous being bent upwards towards the porous structure Including an extension of the structure; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure so that the at least Food leaving one second opening enters the sleeve through the third opening, passes through the sleeve, and leaves the sleeve through the fourth opening; After the intragastric device is deployed in the gastrointestinal tract of the patient, at least a portion of the gastric device is in constant physical contact with a portion of the gastrointestinal tract of the patient without physically attaching to any part of the anatomy of the patient.

Physical contact may be caused by the interlocking action of the small intestine pulling the sleeve of the intragastric device in the small intestine.

The portion of the intragastric device may comprise a portion of the porous structure and the portion of the gastrointestinal tract of the patient may comprise a portion of the stomach adjacent to the pylorus. Optionally, the portion of the stomach comprises the gastric emptying area of the gastrointestinal tract, and the intragastric device does not occlude the area.

The portion of the gastrointestinal device may comprise a portion of the sleeve and the portion of the gastrointestinal tract of the patient may comprise a portion of the pylorus.

The portion of the gastric device may comprise a portion of the sleeve and the portion of the gastrointestinal tract of the patient may comprise a portion of the duodenum.

The intragastric device guides food through itself, allowing food to pass from the stomach of the patient into the small intestine of the patient without blocking the passage of the food. Optionally, at least 10%, and preferably 50%, of food passing from the patient's stomach to the small intestine of the patient passes through the intragastric device.

The intragastric device can provide a constant and substantially complete bypass of the patient's pylori. Optionally, the intragastric device provides a constant and substantially complete bypass of the pyloric and duodenal of the patient.

The present disclosure also discloses a system for promoting weight loss of a patient, the system comprising an intragastric device, a delivery device and a retrieval device, the gastric device configured to be temporarily deployed within the gastrointestinal tract of the patient, the intragastric device A porous structure comprising a top, a bottom and an interior, wherein the porous structure comprises a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. At least one first opening adjacent to and at least one second opening adjacent to the bottom, whereby food enters the porous structure through the at least one first opening, passes through the interior, and the at least one Exit the porous structure through a second opening of the porous structure; A collar positioned at the bottom of the sieve, the collar having a bend, the bend being bent in a direction away from the longitudinal central axis of the porous structure and then the porous being bent upwards towards the porous structure Including an extension of the structure; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure so that the at least Food leaving one second opening enters the sleeve through the third opening, passes through the sleeve, and leaves the sleeve through the fourth opening; After the intragastric device is deployed in the gastrointestinal tract of the patient, the porous structure is located in and in physical contact with a portion of the gastrointestinal tract of the patient, wherein the sleeve allows the gastric device to constantly and substantially complete bypass of the patient's pylorus Located in the pylori and duodenum of the patient to provide a food ingested by the patient may not be in physical contact with any part of the pylori.

Physical contact with the portion of the stomach may be caused by the interlocking action of the small intestine which pulls the sleeve of the intragastric device in the small intestine.

The intragastric device guides food through itself, allowing food to pass from the stomach of the patient into the small intestine of the patient without blocking the passage of the food. Optionally, at least 10%, and preferably 50%, of food passing from the patient's stomach to the small intestine of the patient passes through the intragastric device.

Optionally, the gastric device is not physically attached to any part of the patient's anatomy.

The present disclosure also discloses a system for promoting weight loss of a patient, the system comprising an intragastric device, a delivery device and a retrieval device, the gastric device configured to be temporarily deployed within the gastrointestinal tract of the patient, the intragastric device A porous structure comprising a top, a bottom and an interior, wherein the porous structure comprises a pre-development form having a first volume and a post-development form having a second volume greater than the first volume. At least one first opening adjacent to and at least one second opening adjacent to the bottom, whereby food enters the porous structure through the at least one first opening, passes through the interior, and the at least one Exit the porous structure through a second opening of the porous structure; A collar positioned at the bottom of the sieve, the collar having a bend, the bend being bent in a direction away from the longitudinal central axis of the porous structure and then the porous being bent upwards towards the porous structure Including an extension of the structure; And a sleeve having a flexible elongated body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure so that the at least Food leaving one second opening enters the sleeve through the third opening, passes through the sleeve, and leaves the sleeve through the fourth opening; After the intragastric device is deployed in the gastrointestinal tract of the patient, the porous structure is located in and in physical contact with a portion of the gastrointestinal tract of the patient, wherein the sleeve allows the gastric device to consistently and substantially complete bypass of the duodenum of the patient. Located in the pyloric and duodenum of the patient to provide a food ingested by the patient may not be in physical contact with any part of the duodenum.

System physical contact with the portion of the gastrointestinal tract may be caused by the interlocking action of the small intestine pulling the sleeve of the intragastric device in the small intestine.

The intragastric device guides food through itself, allowing food to pass from the stomach of the patient into the small intestine of the patient without blocking the passage of the food. Optionally, at least 10%, and preferably 50%, of food passing from the patient's stomach to the small intestine of the patient passes through the intragastric device.

Optionally, the gastric device is not physically attached to any part of the patient's anatomy.

The foregoing and other embodiments of the present invention are described in further detail in the detailed description and drawings provided below.

These and other features and advantages of the invention will be appreciated as they are better understood with reference to the following detailed description when considered in connection with the accompanying drawings.
1 is a diagram of the upper gastrointestinal tract;
FIG. 2A is a view of a wire mesh structure in a post-deployment form with a proximal inwardly moving disc or collar attached to its distal end, according to one embodiment of the present disclosure; FIG.
FIG. 2B is a view of the wire mesh structure in a post-deployment form having a proximally curved anti-movement collar formed at its distal end, according to one embodiment of the present disclosure; FIG.
3A illustrates a plurality of free ends or nodes located at the proximal and distal ends of a wire mesh structure, in accordance with an embodiment of the present disclosure;
3B illustrates a plurality of overlapping nodes located at one end of a wire mesh structure, according to one embodiment of the present disclosure;
FIG. 3C illustrates a first plurality of nodes located at one end of the wire mesh structure and a second plurality of nodes proximal to the first plurality of nodes, according to one embodiment of the present disclosure; FIG.
3D is a view of the first and second plurality of nodes at the ends of the wire mesh structure, showing a loop formed in the wires of the first plurality of nodes, according to one embodiment of the present disclosure;
3E is a view of the first and second plurality of nodes at the ends of the wire mesh structure, showing a loop formed within the wires of the second plurality of nodes, according to one embodiment of the present disclosure;
FIG. 3F is a diagram of the first and second plurality of nodes at the ends of the wire mesh structure, showing a loop formed in the alternating wires of both the first and second plurality of nodes, according to one embodiment of the present disclosure. ego;
3G illustrates a wire mesh structure having a first plurality of nodes at its proximal end and a second plurality of nodes at its distal end, according to one embodiment of the present disclosure;
FIG. 3H illustrates a wire mesh structure having first and second plurality of nodes and third and fourth plurality of nodes distributed along its surface at their proximal and distal ends, respectively, according to one embodiment of the present disclosure. Drawing;
3I illustrates various possible node shapes in accordance with multiple embodiments of the present disclosure;
4A is an enlarged view of an atraumatic movement preventing collar of a wire mesh structure of an intragastric device, according to one embodiment of the present disclosure;
4B is an enlarged view of an atraumatic movement preventing collar of a wire mesh structure of an intragastric device, according to another embodiment of the present disclosure;
4C is an enlarged view of an atraumatic movement preventing collar of a wire mesh structure of an intragastric device, according to another embodiment of the present disclosure;
5A is a view of a portion of a sleeve component of an intragastric device in a post-deployment form according to one embodiment of the present disclosure, showing a single wire support forming a spiral along the body of the sleeve;
FIG. 5B is a view of a portion of the sleeve component of the intragastric device in a post-deployment form according to one embodiment of the present disclosure, showing a plurality of wire supports forming spirals along the body of the sleeve; FIG.
5C is a view of a funnel sleeve component of an intragastric device in a post-deployment form in accordance with an embodiment of the present disclosure showing a helical wire loop support on the sleeve;
FIG. 5D is a view of the sleeve component of the intragastric device in a post-deployment form in accordance with an embodiment of the present disclosure showing the funnel opening at the proximal end of the sleeve; FIG.
FIG. 5E is a view of a funnel sleeve component of an intragastric device in a post-deployment form in accordance with an embodiment of the present disclosure showing a plurality of markings on an outer surface of the sleeve body; FIG.
FIG. 5F is a view of a funnel sleeve component of an intragastric device in a post-deployment form according to one embodiment of the present disclosure, showing a marking line extending along the length of the sleeve on the outer surface of the sleeve body; FIG.
5G is a view of a funnel sleeve component of an intragastric device in a post-deployment form according to one embodiment of the present disclosure, showing a marking line and a plurality of markings extending along the length of the sleeve on the outer surface of the sleeve body; ;
6A is a cross-sectional view of a funnel sleeve component of an intragastric device in a post-deployment form in accordance with an embodiment of the present disclosure showing a plurality of sleeve layers;
6B is a cross-sectional view of a funnel sleeve component of an intragastric device in a post-deployment form in accordance with another embodiment of the present disclosure showing a plurality of sleeve layers;
6C is a cross-sectional view of a funnel sleeve component of an intragastric device in a post-deployment form in accordance with another embodiment of the present disclosure, showing a plurality of sleeve layers;
6D is a cross-sectional view of a funnel sleeve component of the intragastric device in a post-deployment form in accordance with another embodiment of the present disclosure showing a plurality of sleeve layers;
6E is a cross-sectional view of a funnel sleeve component of an intragastric device in a post-deployment form according to another embodiment of the present disclosure;
6F is a view of a stent support for a sleeve component of an intragastric device, according to one embodiment of the present disclosure;
FIG. 6G is a view of the sleeve component of the gastric device with the stent support of FIG. 6F;
7 is a view of a funnel sleeve for an intragastric device, according to one embodiment of the present disclosure;
8 is a view of a funnel sleeve for an intragastric device, according to another embodiment of the present disclosure;
FIG. 9A is a view of a wire mesh structure having a sleeve component attached in a post-deployment form according to one embodiment of the present disclosure showing the blunt end of the wire mesh support toward the proximal end of the sleeve; FIG.
9B is a view of a wire mesh structure having a proximal portion of a sleeve component attached in a post-deployment form according to one embodiment of the present disclosure showing a delivery catheter positioned within the wire mesh structure;
10A is a view of a funnel braided short sleeve component in post-deployment form, according to one embodiment of the present disclosure;
FIG. 10B is a view of a funnel braided short sleeve component having a conical distal end in post-deployment form, in accordance with an embodiment of the present disclosure; FIG.
10C is a view of a conical braided short sleeve component in post-deployment form, according to one embodiment of the present disclosure;
FIG. 10D is a view of the conical braided short sleeve component of FIG. 10C attached to a wire mesh structure, in accordance with an embodiment of the present disclosure; FIG.
10E is a view of a conical braided short sleeve component in post-deployment form, according to another embodiment of the present disclosure;
FIG. 10F is a view of the conical braided short sleeve component of FIG. 10E attached to a wire mesh structure, in accordance with an embodiment of the present disclosure; FIG.
FIG. 10G is a view of a conical braided short sleeve component having an atraumatic distal tip in post-deployment form, in accordance with an embodiment of the present disclosure; FIG.
FIG. 10H is a view of a conical braided short sleeve component having an atraumatic distal tip in post-deployment form, in accordance with another embodiment of the present disclosure; FIG.
11A is a cross-sectional view showing one embodiment of an intragastric device with a sleeve attached in post-deployment form;
FIG. 11B is a cross-sectional view illustrating the intragastric device of FIG. 11A in a predeployment form; FIG.
FIG. 11C is a cross-sectional view showing another embodiment of an intragastric device with a sleeve attached in post-deployment form; FIG.
FIG. 11D is a cross-sectional view illustrating the intragastric device of FIG. 11C in a predeployment form; FIG.
12A is a view of a plurality of nodes located at the distal end of a wire mesh structure connected to the proximal end of a funnel sleeve, according to one embodiment of the present disclosure;
12B is a view of a plurality of nodes located at the distal end of a wire mesh structure connected to the proximal end of the funnel sleeve, according to another embodiment of the present disclosure;
12C is a view of a plurality of nodes located at the distal end of a wire mesh structure connected to the proximal end of a funnel sleeve, according to another embodiment of the present disclosure;
12D is a view of a plurality of nodes located at the distal end of a wire mesh structure connected to the proximal end of the funnel sleeve, according to another embodiment of the present disclosure;
12E is a view of a plurality of nodes located at the distal end of a wire mesh structure connected to the proximal end of a funnel sleeve, according to another embodiment of the present disclosure;
12F is a view of a plurality of nodes located at the distal end of a wire mesh structure connected to the proximal end of the funnel sleeve, according to another embodiment of the present disclosure;
FIG. 13A is a view of a plurality of nodes located at a distal end of a wire mesh structure connected to the proximal end of a funnel sleeve, in accordance with an embodiment herein; FIG.
FIG. 13B is a view of the distal end of the mesh structure and the connected proximal end of the funneled sleeve covered with a heat shrink tube, according to one embodiment of the present disclosure; FIG.
14 is a view of an intragastric device having a funnel sleeve in post-deployment form, according to one embodiment of the present disclosure;
15 is a view of an intragastric device having a cylindrical sleeve in post-deployment form, according to one embodiment of the present disclosure;
16A is an enlarged view of a funnel sleeve attached to the anti-moving collar of the wire mesh structure of the gastric device, according to one embodiment of the present disclosure;
16B is an enlarged view of a funnel sleeve attached to the anti-moving collar of the wire mesh structure of the gastric device with a proximal sleeve with a loose edge, according to another embodiment of the present disclosure;
16C is a diagram of an intragastric device including a wire mesh structure and an attached sleeve, according to one embodiment of the present disclosure;
FIG. 16D is a view of the intragastric device of FIG. 16C with the sleeve straightened to show device dimensions for the surrounding anatomy; FIG.
FIG. 16E is a view of a wire mesh structure and sleeve of an intragastric device showing a retractable tow strap on the wire mesh structure, according to one embodiment of the present disclosure; FIG.
16F is a view of the wire mesh structure and sleeve of the gastric device showing a single regenerative tow strap on the wire mesh structure, according to one embodiment of the present disclosure;
17A is a cross-sectional view of the distal end of a sleeve, showing one embodiment of a component designed to configure the distal end to be atraumatic to body tissue;
FIG. 17B is a cross-sectional view of the distal end of a sleeve, showing another embodiment of a component designed to configure the distal end to be atraumatic to body tissue; FIG.
17C is a cross-sectional view of the distal end of a sleeve, showing another embodiment of a component designed to configure the distal end to be atraumatic to body tissue;
18 is a view of the distal end of a sleeve having a positioning tail attached thereto, according to one embodiment of the present disclosure;
19A is a view of the distal end of a sleeve that includes a plurality of fringes coupled to a ring, according to one embodiment of the present disclosure;
19B is a view of the distal end of a sleeve including a plurality of fringes coupled to a ball, according to one embodiment of the present disclosure;
19C is a cross sectional view of a ball attached to the distal end of a sleeve, according to one embodiment of the present disclosure;
19D is a view of the distal end of a sleeve having a plurality of seams extending therefrom and coupled to a ball, according to one embodiment of the present disclosure;
19E is a view of the distal end of a sleeve having at least one seal with attached suture loops or beads extending therefrom according to one embodiment of the present disclosure;
20A is a view of the distal end of a sleeve showing at least one fold of the sleeve wall, according to one embodiment of the present disclosure;
20B is a view of the distal end of the sleeve showing at least one channel and support structure in the sleeve wall, according to one embodiment of the present disclosure;
20C is a view of a portion of a sleeve showing a corrugated sleeve wall, according to one embodiment of the present disclosure;
20D is a view of a portion of a sleeve showing a knitted sleeve wall according to one embodiment of the present disclosure;
FIG. 20E is a view of a portion of a sleeve showing a distal sleeve end having a knitted sleeve wall and an unrolled edge, according to one embodiment of the present disclosure; FIG.
20F is a diagram of an exemplary sleeve knitting pattern, in accordance with various embodiments of the present disclosure;
FIG. 21A is a diagram of an intragastric device having an oval wire mesh structure deployed within the gastrointestinal tract of a patient, according to one embodiment of the present disclosure; FIG.
FIG. 21B is a diagram of an intragastric device having an oval wire mesh structure deployed within the gastrointestinal tract of a patient, according to another embodiment of the present disclosure; FIG.
22 is a view of the expanded wire mesh structure of the first intragastric device and the contracted wire mesh structure of the second intragastric device coupled to the distal end of the implant catheter, in accordance with an embodiment of the present disclosure;
FIG. 23 is an illustration of an intragastric device having a partially shrunk wire mesh structure on a delivery catheter, in accordance with an embodiment of the present disclosure; FIG.
24A is a diagram of a first exemplary delivery device for an intragastric device, in accordance with an embodiment of the present disclosure;
FIG. 24B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 24A, in accordance with an embodiment of the present disclosure; FIG.
25A is a diagram of a second exemplary delivery device for an intragastric device, in accordance with an embodiment of the present disclosure;
FIG. 25B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 25A, in accordance with an embodiment of the present disclosure; FIG.
FIG. 25C is a flowchart illustrating the steps involved in delivering an intragastric device using a delivery device that includes a removable removable sheath, according to one embodiment of the present disclosure; FIG.
FIG. 26A is a diagram of a third exemplary delivery device for an intragastric device, in accordance with an embodiment of the present disclosure; FIG.
FIG. 26B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 26A, in accordance with an embodiment of the present disclosure; FIG.
FIG. 26C is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 26A, in accordance with another embodiment of the present disclosure; FIG.
FIG. 26D is a flow diagram illustrating the steps involved in delivering the wire mesh structure and sleeve separately and assembling the gastric device in the gastrointestinal tract of the patient; FIG.
27A is a diagram of a fourth exemplary delivery device for an intragastric device, in accordance with an embodiment of the present disclosure;
FIG. 27B is another view of the delivery device of FIG. 27A, showing the relative lengths of various components of the delivery device; FIG.
FIG. 27C is a view of the distal end of a delivery device showing a pilot olive for steering, in accordance with an embodiment of the present disclosure; FIG.
FIG. 27D is a diagram of a portion of a delivery device illustrating a mesh retaining component, in accordance with an embodiment of the present disclosure; FIG.
FIG. 27E is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 27A, in accordance with an embodiment of the present disclosure; FIG.
28A is a diagram of a fifth exemplary delivery device for an intragastric device, in accordance with an embodiment of the present disclosure;
FIG. 28B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 28A, in accordance with an embodiment of the present disclosure; FIG.
29A is a diagram of a sixth exemplary delivery device for an intragastric device, in accordance with an embodiment of the present disclosure;
FIG. 29B is a cross-sectional view of a pre-deployed coaxial arrangement of a sleeve of an intragastric device in a delivery device, according to one embodiment of the present disclosure;
29C is a cross sectional view of a pre-deployment coaxial arrangement of a sleeve of an intragastric device in a delivery device, in accordance with another embodiment of the present disclosure;
FIG. 29D is a cross-sectional view of a pre-deployed coaxial arrangement of a sleeve of an intragastric device in a delivery device shown above an endoscope, in accordance with an embodiment of the present disclosure; FIG.
FIG. 29E is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 29A, in accordance with an embodiment of the present disclosure; FIG.
30A is a diagram of a seventh exemplary delivery device for an intragastric device, in accordance with an embodiment of the present disclosure;
FIG. 30B is a diagram of an exemplary embodiment of an external catheter for use in the delivery device of FIG. 30A;
30C is a diagram of another embodiment of an outer catheter showing the dimensions of the compressed sleeve and compressed wire mesh structure of the gastric device relative to the dimensions of the external catheter;
30D is an enlarged view of the distal end of the delivery device of FIG. 30A, showing the pilot component and the proximal and distal spherical components;
FIG. 30E is a view of the proximal end of the delivery device of FIG. 30A, showing an external catheter retracted with the first stop mechanism; FIG.
FIG. 30F is a view of one embodiment of a sleeve of the intragastric device partially deployed corresponding to the external catheter position shown in FIG. 30E;
30G is a view of the proximal end of the delivery device of FIG. 30A, showing an external catheter retracted with a second stop mechanism;
FIG. 30H is a diagram of one embodiment of a wire mesh structure of an intragastric device partially deployed corresponding to the external catheter position shown in FIG. 30I;
30I is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 30A, in accordance with an embodiment of the present disclosure;
FIG. 31A is a diagram of a wire mesh structure of an intragastric device loaded onto a delivery device, according to one embodiment of the present disclosure; FIG.
FIG. 31B is a view of the wire mesh structure of FIG. 31A also loaded on the delivery device; FIG.
FIG. 31C is a view of the wire mesh structure of FIG. 31A loaded on the delivery device such that only the anti-movement collar remains in the loaded sieve; FIG.
FIG. 31D is a view of the wire mesh structure of FIG. 31A fully loaded on the delivery device; FIG.
FIG. 31E is a view of the sleeve of the intragastric device of FIG. 31A partially loaded on the delivery device; FIG.
FIG. 31F is a view of the intragastric device of FIG. 31A fully loaded on the delivery device; FIG.
32A is a diagram of a retrieval device for removing an intragastric device, according to one embodiment of the present disclosure;
FIG. 32B is a flowchart illustrating the steps involved in removing an intragastric device from a patient using the retrieval device of FIG. 31A, in accordance with an embodiment of the present disclosure.

In one embodiment, the present disclosure is directed to a dynamic weight intragastric device used in an obese patient to induce weight loss. In various embodiments, the intragastric device comprises a porous three-dimensional structure having a pre-deployment form and a post-deployment form. In one embodiment, the porous three-dimensional structure is a non-expandable wire mesh structure, or shape memory metal or shape memory that changes from a compressed cylindrical shape before deployment to a significant volume of spherical, oval, kidney beans or any predetermined shape after deployment. It is a spiral structure made of a polymer. In another embodiment, the intragastric device is made of a plastic material, or a polymer such as polyether ether ketone (PEEK) or polyester or bioabsorbable material. The device is changed from predeployed to post-deployed form by a minimum mechanical force and / or a temperature change that rises from the predeployed form at room temperature to the post-deployed form. The device is delivered to the stomach endoscopically through a catheter. The device may be placed via an endoscope, over an endoscope, or over a guide wire with an endoscope or fluoroscopic guidance / assistant device.

The intragastric device has a pre-deployment compression shape to facilitate insertion and a post-deployment expansion shape that lies in the stomach lumen. The volume after deployment of the device is much larger than the volume before deployment. In one embodiment, the device after deployment has a volume of at least 100 mL. After deployment, the device occupies a significant volume in the stomach, thereby reducing the effective gastrointestinal volume available for the storage of ingested food. It limits food intake, induces satiety and suppresses appetite. In one embodiment, the device is also designed to slow gastric emptying by intermittently slowing or blocking food from passing from the stomach to the small intestine using gastrointestinal peristalsis. In various embodiments, the device also functions to produce bilopancreatic diversion by diverting food intake past pancreatic secretions or foods ingesting pancreatic secretions.

In one embodiment, the intragastric device includes a shape memory metal and expands itself when deployed to change from predeployed to post-deployed form. In another embodiment, the intragastric device comprises a temperature sensitive metal that cools to its predeployment form and then self-expands upon exposure to human body temperature to achieve its postdeployment form. In another embodiment, an expansion tool is used to apply a minimum mechanical force that changes the shape of the device from its predeployment form to its postdeployment form. In another embodiment, plastics, polymers, carbon fibers or bioabsorbable materials are used to construct the gastric device.

In one embodiment, the wire structure includes different weighting materials to aid in proper positioning within the stomach. In one embodiment, the lighter weighting material is positioned on top of the wire structure proximate the upper opening and the heavier weighting material is positioned on the bottom of the structure proximate the lower opening. This differential weight ensures that the device is properly positioned within the stomach to achieve the desired effect of slow stomach discharge. The differential weight also provides proper camouflage positioning without the need to physically secure the wire mesh structure to the stomach wall. Differential weight characteristic properties may also be provided by the ingested food material entering the device, and are selectively accumulated towards the bottom of the device, which is facilitated by gravity. Differential weight may also be provided by using different amounts of material in the top and bottom half. The wire mesh structure moves freely within the stomach while still maintaining the correct vertical alignment promoted by gravity.

In one embodiment, the intragastric device includes a wire mesh structure that includes a mesh opening between the wires of the mesh structure when in post-deployment form. In one embodiment, the mesh opening is greater than 1 mm in diameter. In one embodiment, the wires of the wire mesh structure are coated with a corrosion resistant material. The anticorrosive material, once deployed, prevents the exposure of the wire of the wire mesh structure from the acidic gastrointestinal contents and consequently deterioration. The corrosion resistant material completely covers the wires of the wire mesh but does not cover the mesh openings. In one embodiment, the corrosion resistant material comprises parylene. Parylene is advantageous as a coating in that it is durable, can mitigate nickel ion leaching, and has a low profile (thinner when applied). In various embodiments, the corrosion resistant material comprises silicone, polyester, polyether ether ketone (PEEK), medical epoxy, ceramic, additional metal, or any other suitable flexible corrosion resistant material. In one embodiment, the coating metal is tantalum. Tantalum provides corrosion resistance and radiopacity. In one embodiment where the coating is ceramic, the ceramic coating has a thickness of several angstroms. In various embodiments, any one or combination of the above corrosion resistant materials is used to coat the metal of the wire mesh structure.

In one embodiment, the mesh openings are structured differently to regulate the flow of food into and out of the mesh. In one embodiment, at least one opening on the lower half of the device is larger than any of the openings on the upper half of the device, allowing food entering the mesh to escape without having to further reduce the size of the food material.

In another embodiment, the intragastric device further includes a collar or anti-movement component coupled to a portion of its distal end. An anti-movement component similar to the wire mesh of the gastrointestinal device may be configured between the first compressed form for delivery and the second expanded form after deployment. The anti-movement component functions as a physical stopper that prevents the gastric device from passing through the pylorus. In various embodiments, the anti-movement component has a diameter greater than the diameter of the relaxed pyloric. In one embodiment, the anti-movement component includes an extension of the wire mesh structure of the gastric device. In another embodiment, the anti-movement component is a separate piece of wire mesh that is attached to a portion of the distal end of the intragastric device. In various embodiments, the anti-movement component has a shape similar to a bumper, half bumper, disc, saucer or any other shape that prevents the device from moving past the pylorus.

In another embodiment, the sleeve may be attached to an intragastric device, which sleeve extends from the stomach into the empty duodenum, or through the duodenum and into the jejunum. In one embodiment, the sleeve functions to direct sequestered chyme from the wire mesh structure directly to the median duodenum or intermediate jejunum. In another embodiment, the sleeve is coupled to an intragastric device but does not accept food directly from the device. In this embodiment, the proximal end of the sleeve is the distal end of the device and accepts food directly from the stomach or duodenum. Food entering the sleeve is discharged into the duodenum or jejunum by bypassing a portion of the small intestine at the distal end.

Thus, the sleeve acts to bypass a portion of the gastrointestinal (GI) tract to limit absorption of certain substances in the intestine. The benefits provided by the sleeve are similar to those provided by Roux-en-Y gastric bypass surgery, namely weight loss and improvement of type II diabetes.

After implantation, the gastrointestinal tract device, particularly the collar, herein is in constant physical contact with the anatomical structure of the patient without actually being physically attached to the anatomical structure of the patient. This is accomplished by pulling the sleeve down by peristalsis of the small intestine. When the sleeve is pulled down, the collar of the wire mesh structure is in contact with the stomach proximal to the pylorus. The sleeve is in constant physical contact with the pylorus. However, this constant contact with the pylori does not block the passage of food. The opening of the wire mesh structure and the lumen of the sleeve allow food to pass through the pylorus without occlusion at any point, causing food to move into the intestine. The intragastric device herein is physically coupled to the gastrointestinal excretory region of the stomach without completely obstructing the stomach at any point. The intragastric device herein serves as a variable outlet drain and does not act as a stopper for food passage.

The stomach and device herein are designed to maximize the amount of food that is captured and passed through the sleeve to the intestine rather than minimizing the amount of food that is directed to the intestine. By constant contact with the pylorus and stomach, the device is designed to prevent food from passing around and outside the device. In various embodiments, at least 10% of food leaving the patient's stomach passes through the device and does not pass around the device. In one embodiment, at least 50% of the food leaving the patient's stomach passes through the device and does not pass around the device. In various embodiments, the food moved to the device and passing through the sleeve never comes into contact with the duodenum of the patient, thereby allowing the device to function as a true pyloric bypass.

In one embodiment, the device is an inflatable balloon with a sleeve attached, the balloon is not in fluid communication with the lumen of the sleeve, and the balloon serves only to hold the sleeve in place without the need to fix or secure the sleeve to the camouflage wall. . The balloon can be inflated or contracted with the fluid and is designed to be placed in the stomach of a person. The sleeve is flexibly attached to the balloon, has a proximal opening and a distal opening, the proximal opening is designed to lie close to the bulge of the patient and the distal opening is distant from the bulge of the patient. Partially digested food enters the proximal opening and bypasses the bulge zone and exits the distal opening. The sleeve is not fixed or secured to any part of the camouflage wall.

Wire mesh structure

In various embodiments, the intragastric device comprises a porous three-dimensional structure having a pre-deployment form and a post-deployment form. In one embodiment, in the post-deployment form, the intragastric device includes a three-dimensional wire mesh structure that defines an internal volume and has a proximal end and a distal end.

In various embodiments, the wire mesh structure includes a free end or 'node' comprising a curve or curve in the wire of the wire mesh structure, the curve or curve being unsupported and not connected to any other portion of the wire mesh. . In some embodiments, the wire mesh structure includes two plurality of nodes. The first plurality of nodes is located at the proximal end of the structure and the second plurality of nodes is located at the distal end of the structure. When the wire mesh structure is compressed in its predeployment form, each of the first and second plurality of nodes at the proximal and distal ends of the structure are gathered together or "bundled". This results in a larger cross sectional area (or diameter) at the proximal and distal ends of the structure as compared to the cross sectional area of the compressed structure between the ends. As the cross-sectional area increases, the compressed wire mesh structure becomes increasingly difficult to deploy through narrow delivery devices or catheter. This delivery problem can be solved in at least two different ways. In various embodiments, the number of nodes in each of the plurality of nodes is reduced. Reducing the number of nodes in each of the plurality of nodes makes the structure easier to compress and results in a smaller cross-sectional area at the end of the structure. This reduces the force applied to the delivery catheter by the compressed structure, making it easier for the compressed structure to pass through the catheter. In various embodiments, some of the nodes from one or both of the first and second plurality of nodes are moved from the ends of the structure and positioned along the body of the structure, creating an additional plurality of nodes. . The 'staggering' of these nodes reduces the cross-sectional area of the compressed structure at any given point and distributes the force applied by the compressed structure to the delivery catheter, which in turn makes it easier to pass the delivery structure through the catheter. In various embodiments, the number of nodes in each of the plurality of nodes is reduced and the nodes are staggered in the plurality of furnaces throughout the structure to reduce the force applied by the compressed structure and distribute it to the delivery catheter. Reducing and distributing the force allows for easier delivery and the use of delivery catheter with smaller diameter. Reduced and distributed forces also result in larger mesh structures that can be compressed to smaller sizes.

In various embodiments, each of the plurality of nodes includes 10 to 100 individual nodes. In one embodiment, each of the plurality of nodes includes 44 nodes. In another embodiment, each of the plurality of nodes includes 36 nodes. In various embodiments, the wire mesh structure includes 2 to 60 plurality of nodes distributed in latitude directions at different points along its length. In one embodiment, the nodes are staggered such that at least 10% of the total number of nodes in the structure are positioned at the proximal and distal ends. In various embodiments, up to 75% of the total number of nodes is located in any one plurality of nodes. In various embodiments, the nodes are distributed in at least three different lateral nodes along the length of the structure.

The compressibility of the wire mesh structure also depends on the flexibility of the mesh. Flexibility again depends in particular on the thickness of the wire, the wire crossing angle, and the number of wires. With regard to the wire crossing angle, as the wires of the structure are arranged more parallel to each other, the structure becomes more flexible. In various embodiments, the wire mesh structure has a total length of 5 to 50 cm in predeployment form and each wire has a thickness in the range of 0.1 to 1 mm. In one embodiment, each wire has a thickness of 0.44 mm. The wires of the wire mesh structure have a curved deformation that determines how the structure behaves when compressed. In various embodiments, the wire is composed of a shape memory metal such as nitinol in one embodiment. The shape memory metal has a certain curvature strain, beyond which the metal loses the ability to accurately restore the previous shape. Strain (%) can be defined by the following equation.

[Equation 1]

Strain (%) = 2t / R x 100

Where t = wire thickness and R = curve radius. In one embodiment, once the strain reaches 8%, permanent strain is introduced into the shape memory metal so that it no longer fully recovers to its original shape. This factor becomes important when the wire mesh structure is compressed into its predeployment form for delivery. In various embodiments, the wire mesh structure includes at its distal end a collar or circular extension of the wire mesh that functions as an anti-movement component. This collar must be folded in the distal direction during compression so that the compressed structure fits within the delivery device or catheter. The 'projections' of the wire mesh structure are introduced when the collar is folded during compression. Less than 8% strain produces small protrusions in the compressed wire mesh structure that allows the compressed structure to pass easily through the delivery catheter. Thus, in various embodiments, the wire mesh structure is configured to have a wire thickness and a radius of curvature in the collar such that the strain in the collar is 20% or less, preferably 8% or less. In various embodiments, the radius of the collar is less than 10 times the wire thickness. In various embodiments, the percentage of modification ranges from 0.1 to 20%. In various embodiments, the wire of the wire mesh has a thickness of 0.1 to 1.0 mm and the collar has a bending radius of 0.013 to 20 cm. In one embodiment, the wire of the wire mesh has a thickness of 0.4 mm. In various embodiments, the wire thickness and bend radius are configured to satisfy the following description:

2t <R <2000t

Where t = wire thickness and R = curve radius.

In various embodiments, the ends of the wire (s) of the wire mesh structure are terminated in a manner that minimizes the possibility of traumatic damage to body tissues during delivery and withdrawal and during deployment. In some embodiments, the wire mesh structure includes a single wire that is folded into a three dimensional structure. In another embodiment, the wire mesh structure includes one or more wires that are joined and folded into a three-dimensional structure. In various embodiments, the free end of the wire or wires is joined by crimping a titanium tube or nitinol (or other shape memory metal) tube over the free end. In another embodiment, the wire or the free end of the wires are joined by spot welding the free ends together. In one embodiment, the intersections of the wires are not welded. In another embodiment, the intersection of the wires is welded.

sleeve

In various embodiments, the intragastric device herein further includes a flexible sleeve component coupled to the wire mesh structure. In many embodiments, any of the wire mesh structures described above is coupled with any of the sleeve components discussed below. The sleeve component includes an elongate tubular body having a proximal end and a distal end in the lumen.

In one embodiment, the sleeve has a consistent diameter along its entire length. In another embodiment, the sleeve comprises a funnel shape proximal to the proximal end, the diameter of the sleeve being maximum at the first opening at the proximal end of the sleeve body and then reaching a minimum diameter at a position near the midpoint of its length. It gradually decreases as it extends in the distal direction. Then, the diameter is kept constant in the distal direction along the rest of its length.

In various embodiments where the wire mesh structure includes a collar at the distal end, the proximal end of the sleeve is attached to the bottom face of the collar by one of the means listed above. In various embodiments, when the device is compressed in its predeployment form, the sleeve body is pulled to help fold the collar. As noted above, if the proximal end of the sleeve is attached to the bottom surface of the collar, the collar will not fully extend when folded and will result in a large bulge on the collar when the device is in pre-deployment form. The bulge has a large diameter that includes the thickness of the wire mesh structure and is twice the thickness of the sleeve. Thus, in a preferred embodiment, the proximal end of the sleeve is attached to the free end or node of the collar by a plurality of loose sutures. The sleeve is sutured to each node in a manner very similar to the way the fabric of the umbrella is attached to the end of each spine of the umbrella. When the umbrella is folded, the fabric collapses to allow compression. The intragastric device herein functions in a similar manner. In various embodiments, the distal end of the sleeve is pulled when the wire mesh structure is compressed to be loaded onto the delivery device. Loose sutures that attach the sleeve to the node of the wire mesh allow the sleeve to move relative to the wire mesh so that the collar is pulled in the distal direction and extends more straight. Such attachment prevents the formation of large bulges in the collar of the predeployment form. When the sleeve body is pulled during compression, the collar is more fully folded and the resulting bulge has a smaller diameter that includes only the thickness of the wire mesh structure. In various embodiments, there is a minimum to zero overlap between the collar and the sleeve when the intragastric device is in predeployment form. In deployment, the shape memory properties of the wire mesh structure cause the collar to pull the sleeve over the collar as the wire mesh structure expands, such as expanding the fabric when the umbrella is unfolded.

In various embodiments, each node of the distal end of the wire mesh structure (or collar) is attached to the proximal end of the sleeve via a seal. This can result in bulking when attaching the wire mesh structure to the sleeve. Thus, in another embodiment, fewer nodes are sealed in the sleeve. For example, in one embodiment, all other nodes are sealed to the sleeve to reduce the number of suture knots and reduce bulking. The inclusion of adhesive and multiple loops in each suture knot can result in bulking at the point of attachment of the wire mesh structure to the sleeve. As such, in various embodiments, no adhesive is used and each suture knot is limited to one loop. Sealing the sleeve to the node can result in sliding of the suture knot along the length of the wire comprising the node, resulting in the sleeve unintentionally moving relative to the wire mesh structure. In order to prevent sliding, in various embodiments, each suture knot is located in the first engagement portion of the wire adjacent to each node. In practice, each suture rests on two wires and cannot slide along one or the other. To eliminate excessive bulking, in various embodiments, less than all of the first wire bonds are joined to the sleeve. For example, in one embodiment, all other first wire bonds are sealed to the sleeve.

In various embodiments, any sharp end of the wire and / or sleeve of the wire mesh is crimped and loops itself or loops outward to move the sleeve into the intestines or couple the sleeve to the wire mesh structure. It acts as a pulling point for

The distal end of the sleeve is designed to be weighted so that it can be maintained in an elongate shape in which the sleeve extends through a portion of the duodenum. In one embodiment, the sleeve includes a small weight attached to its distal end. In another embodiment, where the second opening at the distal end of the sleeve body is positioned along the sleeve body at its distal end, the distal end of the sleeve body further includes a blind pouch. Blind pouches intermittently capture a small portion of food or fluid. The trapped food or fluid acts to keep the sleeve component long by pushing down the distal end of the sleeve body. In one embodiment, the distal end of the sleeve is reinforced with at least a second layer to keep the distal end positioned downward and to prevent the distal end from curling.

In one embodiment, the sleeve includes a wire mesh configuration having a plurality of nodes similar to the configuration described above for the wire mesh structure.

In another embodiment, the sleeve component includes a membrane that is flexible and compressible by contraction of the small intestine. In one embodiment, the sleeve includes a minimum level of structure that imparts a minimum structural stiffness to the sleeve to resist buckling from camouflage force and maintain function. In one embodiment, the minimum level of structure includes a single structure extending along at least 10% of the sleeve length to provide linear stiffness to the sleeve. In various embodiments, the unitary structure is a straight wire, wire helix, or wire mesh. In one embodiment, the membrane sleeve component includes a plurality of horizontal and / or vertical support elements along the length of the sleeve body. In one embodiment, the horizontal element comprises a wire ring spaced along the length of the sleeve body. In various embodiments, the wire rings are spaced at intervals of 2 to 24 inches. In one embodiment, the rings are spaced six inches apart. In one embodiment, the vertical support element comprises an elongated metal wire. In various embodiments, the wire is 2 to 60 inches in length. In one embodiment, the metal wire is 6 inches long. In another embodiment, the membrane sleeve component includes a helical metal wire extending along its length. The helical metal wire provides support to the sleeve component and maintains its elongate shape. In various embodiments, the helical metal wire is composed of a shape memory metal such as nitinol. Spiral metal wires should not be too tight as they cannot be twisted to recover their complete shape once the sleeve is compressed for delivery. In various embodiments, the helical metal wire of the sleeve has a thickness of 0.1 to 1.0 mm. In one embodiment, the helical metal wire of the sleeve has a thickness of 0.2 mm. As similarly described above with reference to the bend radius of the collar, the bend radius of the helical metal wire of the sleeve should be such that it produces a strain of 0.1-20%, preferably less than 8%. In various embodiments, the percent strain of the helical metal wire can be defined by the following equation:

Where d is the diameter of the wire, Rf is the final radius of curvature and Ri is the initial radius of curvature. Thus, in various embodiments, the helical metal wire has a pitch in the range of 5 to 150 mm. In one embodiment, the helical metal wire has a pitch of 60 mm. In various embodiments, the sleeve includes one or more spiral metal wires to provide greater support while still preventing permanent twisting. In one embodiment, the sleeve comprises three helical metal wires, each individual wire having a pitch of 60 mm, and the wires being spaced apart such that the pitch between the two individual wires is 20 mm. In another embodiment, the sleeve includes six threaded or helical wires to provide structural support to the sleeve. In various embodiments, the membrane of the sleeve component extends proximally over the bottom of the wire mesh structure and covers all or part of the bottom.

The sleeve is flexible and compressible to be constrained in a compressed form on the distal end of the delivery device during delivery. In one embodiment, the sleeve is telescopically shortened to shorten its length to facilitate delivery. In addition, when the device is in its predeployment form, the sleeve can be folded to reduce its length and assist in placement in the delivery device or catheter. In various embodiments, the sleeve itself is folded two to ten times and then folded or wound along the delivery device or catheter for delivery. In one embodiment, the sleeve is supplied coaxially over the guide wire, delivery device or catheter. In another embodiment, the sleeve is folded along the side or around the delivery device or catheter. This prevents the sleeve from sticking to the guide wire and / or the delivery device / catheter when the guide wire and the delivery device / catheter are retracted, which sometimes occurs when the sleeve is coaxially fed over the guide wire or the delivery device / catheter. Encounter.

In another embodiment, some intragastric devices of this embodiment include a sleeve having a length shorter than the length described above. In various embodiments, the short sleeve has an overall length of 100 to 120 mm. In various embodiments, the short sleeve has a funnel shape or a cone shape. In some embodiments, the short sleeve includes a braid having a plurality of nodes or wires formed from the wire mesh structure, similar to the configuration described above for the wire mesh structure. In one embodiment, the braid is created using a single wire. In one embodiment, the wire is made of a shape memory metal. In one embodiment, the shape memory metal is nitinol. In another embodiment, the braid is produced by a machine that braids multiple wires. In some embodiments, the pitch or distance between the nodes is uniform. In another embodiment, the pitch is variable. The ends of the braid are designed to be atraumatic. In one embodiment, the ends are blunt. In another embodiment, the ends are capped with a soft polymer tip. In some embodiments, a portion of the short sleeve is coated with a coating. In some embodiments, the coated portion includes floating nodes. In one embodiment, the coating is silicon. In various embodiments, the diameter of the proximal end of the sleeve is approximately equal to the outer diameter of the anti-movement collar at the distal end of the wire mesh structure. In this embodiment, the proximal end of the sleeve is fitted and attached to the anti-movement collar. In another embodiment, the diameter of the proximal end of the sleeve is less than the outer diameter of the anti-movement collar and is approximately equal to the diameter of the neck of the collar that couples the collar to the wire mesh structure. In these embodiments, the proximal end of the sleeve is attached to the neck of the collar.

In one embodiment, the number of nodes is uniform across the braid. In one embodiment, the number of nodes is 24. In another embodiment, the number of nodes is variable over the braid. For example, in various embodiments, the short sleeve braid includes 24 nodes at the proximal end and 18 or 12 nodes at the distal end. In these embodiments, the node that includes the number of nodes difference between the two ends (eg, six or twelve nodes) is a floating node and is positioned along the body of the short sleeve.

When an intragastric device with a short sleeve is deployed, the short sleeve is not secured to the pylorus and intermittently engages and blocks the pylorus of the patient. This prevents food from passing through the pylorus and allows food to be guided through the short sleeves from the stomach to the duodenum to control gastric emptying. In various embodiments, the opening at the distal end of the short sleeve is between 1 and 30 mm in diameter, where the size of the diameter determines the rate of gastrointestinal discharge. In one embodiment, the opening can be 0 mm when the pylorus is engaged, thereby completely blocking the discharge. Therefore, food can enter the duodenum from the stomach only when the pylorus is unbound or only partially combined.

In various embodiments, the sleeve has a higher coefficient of friction compared to prior art sleeves. In various embodiments, the sleeve has a coefficient of friction in the range of 0.01 to 0.30. In one embodiment, the sleeve has a coefficient of friction of 0.10 or less. In the case of a relatively smooth sleeve, during deployment, the sleeve may break when a smooth sleeve is fixed to the interior of the delivery catheter or to itself to apply a force to free the sleeve. Thus, a sleeve having a rougher outer surface may be supplied to the delivery device or catheter and easier to deploy. In various embodiments, the sleeve includes a matt outer surface. In another embodiment, particulate material or relatively coarse material such as corn starch or biocompatible powder is applied to the outer surface of the sleeve prior to loading and deploying the sleeve to the delivery device.

In various embodiments, the sleeve includes one or more radiopaque markers to ensure proper positioning of the sleeve using radiography. In various embodiments, the radiopaque marker includes a plurality of individual markings along the outer surface of the sleeve body. In another embodiment, the radiopaque marker includes a single line extending along the outer surface of the sleeve body. The helical single line may indicate the twist of the sleeve. In another embodiment, the radiopaque marker includes a plurality of individual markings and a single line extending along the outer surface of the sleeve body. In another embodiment, radiopaque marking is not necessary when the wire thickness of the support element of the sleeve is large enough to allow radiographic visualization.

Recovery mechanism

In various embodiments, a wire mesh structure having a wire mesh structure or a coupled sleeve component may include one or more retrieval mechanisms having at least one retrieval mechanism positioned proximate at least one opening at a proximal end of the wire mesh structure. Include. In one embodiment, the recovery mechanism includes 80 lb of recovery closure.

Movement prevention component

In various embodiments, a wire mesh structure having a wire mesh structure or a coupled sleeve component includes one or more anti-movement components or collars. In one embodiment, the movement preventing component is made of metal. In one embodiment, the metal is a shape memory metal, such as nitinol. The anti-movement component is preferably positioned at the distal end of the wire mesh structure (at the junction of the wire mesh structure and the sleeve component in the embodiment of the device including the sleeve) and once the device is deployed, close to the pylorus It will settle down. The anti-movement component has the function of preventing passage of the wire mesh structure or the entire device through the pyloric.

In various embodiments, various components of the device, including wire mesh structures, retrieval mechanisms, and / or anti-movement components, are coated with a therapeutic drug to enhance the functionality of the device.

In various embodiments, the wire mesh structure, hooks, and / or anti-movement components include radiopaque markers for radiographic visualization to facilitate delivery and retrieval. In various embodiments, the wire mesh structure, hooks, and / or anti-movement components include ultrasonic markers for ultrasonic visualization to facilitate delivery and withdrawal.

Delivery device

The present disclosure also discloses various embodiments of a delivery device used to deploy an intragastric device into the gastrointestinal tract of a patient. The gastric device is preloaded on the delivery device, and the delivery device is used to carry the wire mesh of the gastric device into the stomach and the sleeve of the gastric device into the proximal small intestine.

In one embodiment, the delivery device comprises an elongated tubular body having a coaxial plunger and a catheter and a plurality of handles. The handle is manipulated to deploy the sleeve and wire mesh structure of the intragastric device in multiple stages. In one embodiment, the tubular body includes a trigger that controls the movement of various components of the delivery device to achieve deployment of the gastric device.

In various embodiments, the gastric device may be recovered using standard overtubes, endoscopes, and grasper.

The present invention relates to a number of embodiments. The following disclosure is provided to enable any person skilled in the art to practice the invention. The expression used herein should not be construed as a general negation of any one particular embodiment, and should not be used to limit the claims beyond the meaning of the terms used in the claims. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terms and phrases used are for the purpose of describing exemplary embodiments and should not be regarded as limiting. Accordingly, the present invention is intended to cover the widest range including many variations, modifications, and equivalents consistent with the disclosed principles and features. For the sake of clarity, details regarding technical data known in the art related to the present invention have not been described in detail so as not to unnecessarily obscure the present invention.

1 is a diagram of the upper gastrointestinal tract. After swallowing, the food passes rapidly through the esophagus 111 into the stomach 112. There, the food is digested for a period of time, crushed and mixed with gastric juice to undergo the process of dilution to an isotonic concentration. The stomach 112 is relaxed to accommodate the volume of digested food. As the stomach 112 is filled with food, a feeling of satiety or fullness is generated by the kidney receptors in the stomach wall and the person stops eating. Isotonic foods, known as succulents, then pass through the pylori 113 into the duodenum 114. Passage of the nectar into the duodenum 114 results in the release of enzyme-rich and secretion from the pancreas 115 and bile acid-rich bile secretions from the liver 116. The bile secretions proceed through the common bile duct 117, where they are combined with pancreatic secretions that reach through the pancreatic duct 118, and the two tubes are combined to form the batter bulge 119. Barter bulge 119 serves as an inlet point for secretion to settle into the duodenum. Within the plant 120, mixing of the juice and pancreatic and bile secretions results in the digestion of proteins, fats, and carbohydrates, which are then absorbed into the bloodstream.

2A illustrates a wire mesh structure 201 of an intragastric device in a post-deployment form having a proximal inward movement disk or collar 204 extending from or attached to its distal end, according to one embodiment of the present disclosure. ). The wire mesh structure 201 includes a three dimensional porous structure having an internal volume. The wire mesh structure 201 has an ovoid shape and includes a recovery mechanism 203. In one embodiment, the recovery mechanism is a silk suture loop. In one embodiment, the recovery mechanism is an 80 lb recovery seal. The anti-movement collar 204 is inclined proximally including the distal portion of the wire mesh structure 201 that is folded such that the distally directed end of the wire mesh structure 201 is directed towards the proximal end of the wire mesh structure 201. Lose. In another embodiment, the collar 204 includes any curved / atraumatic structure circumferentially positioned about the distal end of the wire mesh structure 201. The collar 204 helps to prevent the wire mesh structure 201 from entering and passing through the pylorus. In one embodiment, the wire mesh structure 201 includes a mantle, primarily a spherical or oval proximal end and an expanded distal end. In one embodiment, the distal half of the structure is covered with a membrane to prevent passage of food from the structure 201, leading to food through the distal opening. In one embodiment, structure 201 has an optional non-return valve at its proximal end and another optional valve at its distal end. The valve at the distal end acts to control the flow of succulent or partially digested food from the interior of the structure 201 to the exterior of the structure 201.

FIG. 2B is a view of the wire mesh structure 210 in a post-deployment form with a proximally curved anti-movement collar 214 formed at its distal end, according to one embodiment of the present disclosure. Wire mesh structure 210 has an ovoid shape having a proximal end and a distal end. The wire mesh structure 210 includes staggered nodes 216, 218 in its body to facilitate compression for delivery and removal. Wire mesh structure 210 also includes a set of nodes 217 staggered at its proximal end. Staggered nodes 217 at the proximal end provide a location for gripping, thereby improving ease of recovery. The anti-movement collar 214 is formed from a continuous portion of the wire of the wire mesh structure 210 at its distal end. The anti-movement collar 214 flexes proximally toward the body of the wire mesh structure 210, and the ends 215 are formed in a rounded manner so as to be atraumatic to the body tissue. In various embodiments, the wire mesh structure 210 does not have sharp edges and is high enough to prevent the occurrence of abrasions and to prevent any significant or permanent deformation and passage through the pylorus by gastric contraction, but the wire mesh structure ( The radial force is low enough so that 210 does not have too rigidity and is affected by gastric contraction sufficient to facilitate the movement of food through the wire mesh structure 210. In some embodiments, the wire mesh structure is capable of withstanding up to 200 mm Hg of shrinkage without being fully compressed.

FIG. 3A illustrates a plurality of free ends or nodes 301, 302 located at the proximal and distal ends of the wire mesh structure, according to one embodiment of the present disclosure. Node 301 is located at the proximal end of the wire mesh structure and node 302 is located at the distal end of the wire mesh structure. The nodes include bends or bends in the wires of the wire mesh structure that are not supported or connected to other portions of the wire mesh. In other words, the node is a loop or bend that includes a free end at each end of the wire mesh structure. Each wire mesh structure includes at least two plurality of nodes, namely one plurality of nodes 301 at its proximal end and at least one plurality of nodes 302 at its distal end. Other wire mesh structure embodiments, such as those described below with reference to FIGS. 3B and 3C, include more than two plurality of nodes that impart greater compressibility to the wire mesh structure. Such wire mesh structures include free ends or nodes located at lateral positions along the body length of the structure, in addition to the free ends or nodes at each free end of the structure.

3B illustrates a plurality of overlapping nodes 303 located at one end of a wire mesh structure, according to one embodiment of the present disclosure. As shown in FIG. 3B, the nodes 303 are all located in the same lateral position. This creates an expansion in said lateral position when the wire mesh structure is compressed in its predeployment form. The inflation creates drag on the delivery device or catheter during delivery of the wire mesh structure. 3C illustrates a first plurality of nodes 304 located at one end of the wire mesh structure and a second plurality of nodes located proximal to the first plurality of nodes 304, according to one embodiment of the present disclosure. 305 is a view showing. The two plurality of nodes 304, 305 are crossed across two different lateral positions of FIG. 3C. The staggering of the nodes produces smaller inflation when the wire mesh structure is compressed in its predeployed form, resulting in less drag applied to the delivery device or catheter and thus easier transfer and withdrawal of the wire mesh structure.

FIG. 3D is a view of the first and second plurality of nodes at the ends of the wire mesh structure, showing a loop 308 formed within the wires of the first plurality of nodes 306, according to one embodiment of the present disclosure. 306, 307). Referring to FIG. 3D, the loop 308 extends in the direction toward the center of the wire mesh structure. In another embodiment, the loop extends outwardly in a direction away from the center of the wire mesh structure. In some embodiments, loop 308 functions as an attachment point for other device components, such as sleeve components, as also described with reference to FIGS. 4B and 4C.

FIG. 3E illustrates the first and second plurality of nodes 316, at the ends of the wire mesh structure, showing loops 318 formed in the wires of the second plurality of nodes 317, according to one embodiment of the present disclosure. 317). FIG. 3F is an end of a wire mesh structure, showing loops 313, 314 formed in alternating wires of both first and second plurality of nodes 310, 319, according to one embodiment of the present disclosure. A diagram of the first and second plurality of nodes 310, 319. The wire loop embodiment shown in FIGS. 3D-3F merely discloses various options for node looping and is not intended to be limiting. In various embodiments, any number or percentage of wires of the first plurality of nodes, the second plurality of nodes, or the first and second plurality of nodes may be looped. For example, in one embodiment, only the outermost node is looped about the center of the wire mesh structure. In another embodiment, only nodes proximal to the outermost node are looped. In some embodiments, 0 to 100% of the nodes are looped. In one embodiment, 50% of the nodes are looped. In another embodiment, 30% of the nodes are looped.

FIG. 3G illustrates a wire mesh structure 315 having a first plurality of nodes 311 at its proximal end and a second plurality of nodes 312 at its distal end, according to one embodiment of the present disclosure. to be. The wire mesh structure 315 of FIG. 3G includes the smallest number of nodes (two) possible and will have maximum inflation at its proximal and distal ends when compressed in its predeployment form. 3H illustrates first and second plurality of nodes 321, 322 and third and fourth plurality of nodes 323 distributed along their surface at their proximal and distal ends, respectively, according to one embodiment of the present disclosure. 324 is a diagram illustrating a wire mesh structure 320. The increased number of multiple nodes allows fewer fewer individual nodes to be located in the lateral position of each of the plurality of nodes. As such, when compressed, the wire mesh structure will include inflation at each lateral position of each of the plurality of nodes, but each inflation portion is proximal and distal generated when the wire mesh structure shown in FIG. 3G is compressed. The diameter will be smaller than the inflation at the end. Thus, the compressed predeployment form of the wire mesh structure of FIG. 3H will produce less drag on the delivery device or catheter, and will be easier to deploy. Although four plurality of nodes 321, 322, 323, 324 are shown in wire mesh structure 320 of FIG. 3H, the wire mesh structure may have three or more than four nodes. In various embodiments, the wire mesh structure includes 2 to 60 plurality of nodes located at different lateral positions.

FIG. 3I illustrates various possible node shapes in accordance with multiple embodiments of the present disclosure. FIG. Possible node shapes are at the ends of safety pins 335, including sharp bends 331, shallow bends 332, sharp bends 333, circular bends 334, and wire loops 345 at the ends of the nodes. Include similar shapes.

4A is an enlarged view of an atraumatic movement preventing collar 414 of the wire mesh structure 410 of the gastric device 400, according to one embodiment of the present disclosure. The anti-movement collar 414 has a rounded bulbous shape and includes a rounded end 415 extending proximally toward the wire mesh structure 410. The rounded end 415 is designed to be atraumatic to body tissue. As discussed above, in some embodiments, the end 415 is separated into various nodes to prevent multiplexing of the wire during compression, which may induce erosion. The long axis of the collar 412 is curved at an angle 413 greater than 90 ° compared to the long axis of the mesh 411 such that the rounded end 415 is directed in the direction towards the wire mesh structure 410.

4B is an enlarged view of an atraumatic movement preventing collar 424 of the wire mesh structure 421 of the gastric device 420, according to another embodiment of the present disclosure. The anti-movement collar 424 includes a rounded end 425 having an annular bulb shape and extending proximally toward the wire mesh structure 421. The rounded end 425 is designed to be atraumatic to body tissue. In some embodiments, end 425 is separated into various nodes 427l and 427s to prevent bundling of the wire during compression, which may lead to erosion. The node includes an elongated node 427l and a short node 427s, where the elongated node 427l again extends further proximally toward the top of the wire mesh structure 421 than the short node 427s. In some embodiments, collar 424 includes nine elongated nodes 427l and nine short nodes 427s. The free end of elongate node 427l includes a hoop 428 for sealing the proximal end of the sleeve component. Hoop 428 extends outwardly away from the free end of elongate node 427l. In one embodiment, hoop 428a is formed from twisting the free end of elongate node 427l into a hoop shape. In another embodiment, the hoop 428b includes a separate wire hoop sealed at the free end of the elongated node 427l. In some embodiments, once the sleeve is attached, additional suture knots are placed at the joints of the torsion or individual wire hoops to prevent sliding of the sleeve attachment.

4C is an enlarged view of an atraumatic movement preventing collar 434 of the wire mesh structure 431 of the gastric device 430, according to another embodiment of the present disclosure. The anti-movement collar 434 includes a rounded end 435 having an annular bulb shape and extending proximally toward the wire mesh structure 431. The rounded end 435 is designed to be atraumatic to body tissue. In some embodiments, end 435 is separated into various nodes 437l and 437s to prevent bundling of the wire during compression, which may lead to erosion. The node includes an elongate node 437l and a short node 437s, where the elongate node 437l again extends further proximally toward the top of the wire mesh structure 431 than the short node 717s. In some embodiments, collar 434 includes nine elongated nodes 437l and nine short nodes 437s. The free end of elongate node 437l includes a hoop 439 for sealing the proximal end of the sleeve component. The hoop 439 extends inward toward the curve at the distal end of the wire mesh structure 431. In one embodiment, the hoop 439a is formed from looping the free end of the elongated node 437l into a hoop shape. In another embodiment, the hoop 439b includes a separate wire hoop sealed at the free end of the elongated node 437l. In some embodiments, once the sleeve is attached, additional suture knots are placed at the joints of the loops or individual wire hoops to prevent sliding of the sleeve attachment.

In some embodiments, the sleeve component is attached to the distal end of the wire mesh structure or the collar of the intragastric device. In various embodiments, the sleeve component of the present application may be coated with polytetrafluoroethylene (PTFE) or polyethylene or cast PTFE (eg, Teflon), fluorinated ethylene propylene (FEP) or perfluoroalkoxy (PFA) coatings. With PTFE, PFA, extruded FEP and extruded PFA or extruded PTFE or fluoropolymer or silicone. In one embodiment, the silicone sleeve is made by hand pouring and braiding. In another embodiment, the silicone sleeve is manufactured by machine braiding. In various embodiments, the sleeve component has a length in the range of 6 inches to 6 feet or more. In one embodiment, the sleeve component has a length of 24 inches. In another embodiment, the sleeve component has a length of 30 inches. In various embodiments, the sleeve component has a diameter in the range of 1 cm to 10 cm. In one embodiment, the sleeve component has a diameter of 3 cm.

5A shows a portion of the sleeve component 500 of the intragastric device in a post-deployment form in accordance with one embodiment of the present disclosure, showing a single wire support 501 forming a spiral along the body of the sleeve 500. It is a drawing of. The metal wire needs to have a helix that must be taut enough to provide support but once the sleeve is in compression for delivery, it will not be too taut to be twisted and unable to recover its full shape. Referring to FIG. 5A, the helical metal wire 501 has a pitch shown by the length l, which is 60 mm. With a wire thickness of 0.1 to 1 mm, this pitch gives the helical metal wire a strain that will be less than 20%, preferably less than 8%.

5B illustrates a plurality of wire supports 506, 507, 508 forming spirals along the body of the sleeve 505, the sleeve components of the intragastric device in post-deployment form according to one embodiment of the present disclosure. 505 is a diagram of a portion. The sleeve still contains more than one spiral metal wire to provide greater support while preventing permanent twisting. Referring to FIG. 5B, each individual wire 506, 507, 508 has a pitch shown by a length l _{1 that} is 60 mm. The wires 506, 507, 508 are spaced apart so that the pitch between the two individual wires shown by the length l ₂ is 20 mm.

5C is a view of the funneled sleeve component 510 of the intragastric device in a post-deployment form according to one embodiment of the present disclosure, showing the spiral wire loop supports 511, 513 on the sleeve 510. In the embodiment shown in FIG. 5C, the sleeve 510 includes two sets of wire loop supports 511, 513. Each set of wire loop supports 511, 513 includes a loop comprising two separate wires for a total of four wires on the sleeve 510. Each wire loop support 511, 513 is finished with a blunt end 515 to be atraumatic to body tissue. The wire loop supports 511, 513 are twisted in a helical configuration and looped along the length of the sleeve 510. In one embodiment, the pitch or distance between each loop 511, 513 (and between each wire of each loop 511, 513) is defined by the length l and is approximately 15 mm.

FIG. 5D is a view of the sleeve component 520 of the intragastric device in a post-deployment form in accordance with an embodiment of the present disclosure showing the funnel opening 521 at the proximal end of the sleeve. The funnel opening 521 is good for attachment to a node of a collar located at the distal end of the wire mesh structure of some embodiments of the intragastric device herein, as described in detail below with reference to FIGS. 11C and 11D. Is suitable.

FIG. 5E is a diagram of a funnel sleeve component 525 of the intragastric device in a post-deployment form according to one embodiment of the present disclosure showing a plurality of markings 527 on the outer surface of the sleeve body. Markings 527 are radiopaque and their radiographic visualization assists in proper placement of the sleeve during device delivery.

FIG. 5F illustrates a funnel sleeve component of the intragastric device in a post-deployment form in accordance with one embodiment of the present disclosure, showing a marking line 533 extending along the length of the sleeve 530 on the outer surface of the sleeve body. 530 is a diagram. Line 533 is radiopaque and its radiographic visualization assists in proper placement of the sleeve during device delivery. In addition, the spiraling or rotation of a line about the central axis of the sleeve may indicate the twist of the sleeve.

FIG. 5G shows an intragastric device in a post-deployment form in accordance with one embodiment of the present disclosure, showing a marking line 538 and a plurality of markings 537 extending along the length of the sleeve 535 on the outer surface of the sleeve body. Is a diagram of a funnel sleeve component 535 of FIG. The markings 537 and line 538 are radiopaque and their radiographic visualization assists in proper placement of the sleeve during device delivery and helps to detect twisting of the sleeve 535.

6A is a cross-sectional view of a funnel sleeve component 600 of the intragastric device in a post-deployment form in accordance with one embodiment of the present disclosure showing a plurality of sleeve layers 606, 607, 608, 609. In one embodiment, the sleeve layers 606, 607, 608, 609 are composed of PTFE. The sleeve 600 is approximately 0.06 mm thick and includes an innermost first layer 606 extending in a configuration along the length of the sleeve. The first layer 606 extends along the entire length of the sleeve 600. Sleeve 600 includes a second layer 607 that overlaps the first layer 606, which is approximately 0.06 mm thick and only proximal 616 and sleeve 600 of sleeve 600. Extends only along distal portion 618. In one embodiment, the proximal portion 616 includes a funnel portion 601 and an additional portion having a length l ₁ extending approximately 30 to 40 mm distal beyond the funnel portion 601. In one embodiment, the sleeve 600 includes a distal end having a length l ₂ of approximately 20 to 30 mm. Distal portion 618 includes only approximately the maximum proximal 10 mm of length l ₂ . In one embodiment, the second layer 607 extends in configuration along the width of the sleeve 600. Sleeve 600 includes a second layer 607 and a third layer 608 that overlaps a central portion 617 of the first layer 606. The third layer 608 is approximately 0.06 mm thick and extends in configuration along the width of the sleeve 600. The sleeve 600 includes a fourth layer 609 overlapping the third layer 608, which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve 600. Thus, in the embodiment shown in FIG. 6A, the sleeve 600 has four layers in its proximal section 616, three layers in its central section 617, and four layers in its distal section 618. It includes. Layers 606, 607, 608, 609 are interlayer cross-bonded or applied in different configurations (along the width along the length of sleeve 600) to provide additional durability to the sleeve. In one embodiment, the sleeve 600 is between the second layer 607 and the third layer 608 (or the first layer 606 and the third layer 608 at the central portion 617 of the sleeve 600). In between] further comprises a metal wire support 605 to provide structural support. In one embodiment, the sleeve includes sutures 619 for connection to the wire mesh structure.

6B is a cross-sectional view of the funneled sleeve component 620 of the intragastric device in a post-deployment form according to another embodiment of the present disclosure, showing a plurality of sleeve layers 626, 627, 628, 629, 630. In various embodiments, the sleeve layers 626, 627, 628, 629, 630 may be any one of polytetrafluoroethylene (PTFE), low density polyethylene (LDPE), high density polyethylene (HDPE), and ultra high molecular weight polyethylene (UHMWPE). Or a combination. In one embodiment, the sleeve 620 includes an innermost first PTFE layer 626 that is approximately 0.06 mm thick and extends in configuration along the length of the sleeve. The first PTFE layer 626 extends along the entire length of the sleeve 620. Sleeve 620 includes a second PTFE layer 627 that overlaps the first PTFE layer 626, which is approximately 0.06 mm thick and only proximal 636 and sleeve of sleeve 620. Extends only along distal portion 638 of 620. In one embodiment, the proximal portion 636 includes a funnel portion 621 and an additional portion having a length l ₁ extending approximately 30 to 40 mm distal beyond the funnel portion 621. In one embodiment, the sleeve 620 includes a distal end having a length l ₂ of approximately 20 to 30 mm. The distal portion 638 comprises only about the largest proximal 10 mm of length l ₂ . In one embodiment, the second PTFE layer 627 extends in configuration along the width of the sleeve 620. Sleeve 620 includes a third PTFE layer 628 that overlaps the central portion 637 of the second PTFE layer 627 and the first PTFE layer 626. The third PTFE layer 628 is approximately 0.06 mm thick and extends in configuration along the width of the sleeve 620. The sleeve 620 includes a fourth PTFE layer 629 overlapping the third PTFE layer 628, which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve 620. . In one embodiment, the sleeve further includes a fifth PTFE layer 630 interposed between the third PTFE layer 628 and the fourth PTFE layer 629. In one embodiment, the fifth PTFE layer 630 is approximately 0.06 mm thick and extends in configuration along the length of the sleeve 620. Thus, in the embodiment shown in FIG. 6B, the sleeve 620 has a total of five layers in its proximal section 636, four layers in its central section 637, and a total of its distal section 638. It contains five layers. In various embodiments, layers 626, 627, 628, 629, and 630 are interlayer cross-bonded or applied in different configurations (along the width along the length of sleeve 620) to provide additional durability to the sleeve. to provide. In one embodiment, the sleeve 620 is between the second PTFE layer 627 and the third PTFE layer 628 (or the first PTFE layer 626 and the third PTFE at the central portion 637 of the sleeve 620). Between layer 628] further includes a metal wire support 625 to provide structural support. In one embodiment, the sleeve includes sutures 639 for connection to the wire mesh structure.

6C shows a plurality of sleeve layers 643, 644, 646, 647, 648, 649, 650, a funnel sleeve component 640 of the intragastric device in a post-deployment form in accordance with one embodiment of the present disclosure. It is a cross section of. In various embodiments, the sleeve layers 643, 644, 646, 647, 648, 649, 650 may be polytetrafluoroethylene (PTFE), low density polyethylene (LDPE), high density polyethylene (HDPE), and ultra high molecular weight polyethylene (UHMWPE). Consisting of any one or combination of the two. In one embodiment, sleeve 640 includes an innermost first PTFE layer 643 that is approximately 0.06 mm thick and extends in configuration along the length of the sleeve. First PTFE layer 643 extends along the entire length of sleeve 640. The sleeve 640 includes a second PTFE layer 644 that overlaps the first PTFE layer 643, which is approximately 0.06 mm thick and only proximal 656 of the sleeve 640 and Extends only along distal portion 658 of sleeve 640. In one embodiment, the proximal portion 656 includes a funnel portion 641 and an additional portion having a length l ₁ extending approximately 30 to 40 mm distal beyond the funnel portion 641. In one embodiment, the sleeve 640 includes a distal end having a length l ₂ of approximately 20 to 30 mm. The distal portion 658 includes only the maximum proximal 10 mm of approximately the length l ₂ . In one embodiment, the second PTFE layer 644 extends in a configuration along the width of the sleeve 640. Sleeve 640 includes a third PTFE layer 646 overlapping the central portion 657 of the second PTFE layer 644 and the first PTFE layer 643. The third PTFE layer 646 is approximately 0.06 mm thick and extends in configuration along the width of the sleeve 640. The sleeve further includes a first intermediate PTFE layer 648 and a second intermediate PTFE layer 649 interposed between the second PTFE layer 644 and the third PTFE layer 646. In one embodiment, the first intermediate PTFE layer 648 and the second intermediate PTFE layer 649 are both approximately 0.06 mm thick. In one embodiment, both the first intermediate PTFE layer 648 and the second intermediate PTFE layer 649 extend in a configuration along the length of the sleeve 640. In another embodiment, the first intermediate PTFE layer 648 and the second intermediate PTFE layer 649 both extend in a configuration along the width of the sleeve 640. In another embodiment, the first intermediate PTFE layer 648 extends in the configuration along the length of the sleeve 640, and the second intermediate PTFE layer 649 extends in the configuration along the width of the sleeve 640. In another embodiment, the first intermediate PTFE layer 648 extends in the configuration along the width of the sleeve 640, and the second intermediate PTFE layer 649 extends in the configuration along the length of the sleeve 640. Sleeve 640 includes a fourth PTFE layer 647 overlying the third PTFE layer 646, which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve 640. . The sleeve further includes a third intermediate PTFE layer 650 interposed between the third PTFE layer 646 and the fourth PTFE layer 647. In one embodiment, third intermediate PTFE layer 650 is approximately 0.06 mm thick and extends in configuration along the length of sleeve 640. Thus, in the embodiment shown in FIG. 6C, the sleeve 640 has a total of seven layers in its proximal section 656, a total of six layers in its central section 657, and a total of its distal section 658. Contains seven layers. In various embodiments, layers 643, 644, 646, 647, 648, 649, 650 may be interlayer cross-bonded or applied in different configurations (along the width along the length of sleeve 640) to the sleeve. Provides additional durability. In one embodiment, the sleeve 640 further includes a metal wire support 645 between the first intermediate PTFE layer 648 and the second intermediate PTFE layer 649 to provide structural support. In one embodiment, the sleeve includes a suture point 659 for connection to the wire mesh structure.

6A-6C show a sleeve having a plurality of PTFE layers, these configurations are not intended to be limiting and may include more or fewer PTFE layers or layers, including other materials having various stacks of individual layers. Other sleeve embodiments are contemplated.

FIG. 6D is a cross-sectional view of the funneled sleeve component 660 of the intragastric device in a post-deployment form in accordance with another embodiment of the present disclosure showing a plurality of sleeve layers. The sleeve includes a cylindrical portion 660c and a funnel portion 660f. In some embodiments, the cylindrical portion 660c has a length l _c of approximately 500 mm and the funnel portion has a length l _f of approximately 100 mm. Sleeve component 660 of FIG. 6D consists of a single machine braided wire 661 sandwiched between multiple sleeve layers. In one embodiment, the single machine braided wire 661 is in an axially stretched configuration. The single machine braided wire 661 extends only along the proximal portion of the cylindrical portion 660c of the sleeve 660. In one embodiment, approximately 450 mm of the proximal portion of the cylindrical portion 660c of the sleeve 660 comprises a single machine braided wire 661, while at least 50 mm at the distal end of the sleeve 660 is Does not contain wires In one embodiment, the distal end of the sleeve 660 includes a distal opening 682 having a diameter of approximately 24.5 mm. The funnel portion 660f includes a wire support 671 that terminates proximally at the plurality of nodes 672. In one embodiment, the sleeve 660 includes alternating long and short nodes as described above and includes a total of 18 nodes spaced at equal intervals from each other. In some embodiments, the sleeve layer extends proximally past the long node at a distance of at least 5 mm. In one embodiment, the proximal end of the sleeve 660 includes a proximal opening 681 having a diameter of approximately 63 mm. In various embodiments, the single machine braided wire 661 and the wire support 671 each comprise a wire having a diameter in the range of 0.100 to 0.150 mm. In one embodiment, the single machine braided wire 661 and the wire support 671 each comprise a wire having a diameter of 0.127 mm. In another embodiment, the single machine braided wire 661 and the wire support 671 each comprise a wire having a diameter of 0.140 mm.

Sleeve 660 includes an innermost first PTFE layer 662 extending in a configuration along the width of sleeve 660. The first PTFE layer 662 extends along the entire length of the sleeve 660. In one embodiment, the first PTFE layer 662 has a thickness of approximately 0.06 mm. A single machine braided wire 661 overlaps the first PTFE layer 662 along the proximal portion of the cylindrical portion 660c, and a wire support 671 along the funnel portion 660f of the sleeve 660. Overlaps first PTFE layer 662. The proximal intermediate PTFE layer 663p overlaps the wire support 671 along the funnel portion 660f and is approximately 5-7 over a single machine braided wire 661 of the cylindrical portion 660c of the sleeve 660. mm distal to the distal side. The distal intermediate PTFE layer 663d overlaps the first PTFE layer 662 at the distal end of the sleeve and is approximately 5-7 over a single machine braided wire 1601 of the cylindrical portion 660c of the sleeve 660. mm proximally. A plurality of cylindrical intermediate PTFE layers 663c overlap the single machine braided wire 661 along the section of the cylinder of the sleeve 660. In some embodiments, sleeve 660 comprises three cylindrical intermediate PTFE layers 663c, each of which has a length of approximately 3 to 5 mm and from each other and at each of the proximal and distal ends of the sleeve. 70-80 mm from the proximal intermediate PTFE layer 663p and the distal intermediate PTFE layer 663d. Sleeve 660 is approximately 0.06 mm thick and includes an outermost second PTFE layer 664 extending in a configuration along the length of sleeve 660.

In some embodiments, sleeve 660 further includes at least one marker for visualization in radiographic examination to determine proper placement after delivery. 6D, the sleeve is close to the proximal end of the single machine braided wire 661, close to the center of the single machine braided wire 661, and to the distal end of the single machine braided wire. Three markers 665 located in close proximity. In one embodiment, each marker 665 is covered and held in place by a patch 666 of PTFE having a length of approximately 5 mm, a width of approximately 5 mm, and a thickness of approximately 0.06 mm. In one embodiment, the markers 665 are separated from each other by a distance of approximately 145 mm to 155 mm. In one embodiment, the marker 665 is located in all alternative cylindrical intermediate PTFE layers 663c. In one embodiment, the marker 665 is located on one side of the sleeve 660. In one embodiment, the marker 665 is a tantalum marker.

6A-6D, in various embodiments, the sleeve layer comprised of PTFE may also be comprised of polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), and ultra high molecular weight polyethylene (UHMWPE). As an alternative to being bonded, the sleeve layer may be sealed.

6E is a cross-sectional view of the funneled sleeve component 690 of the intragastric device in a post-deployment form according to another embodiment of the present disclosure. Referring to FIG. 6E, the sleeve 690 includes a proximal funnel portion 690p and a distal cylinder portion 690d. Proximal portion 690p includes a manually braided nitinol wire mesh 691 covered with PTFE. Distal portion 690d includes a mechanical braided nitinol wire mesh 692 covered with PTFE. Distal portion 690d also includes at least one fluoropolymer band 695 overlaid for improved bonding of PTFE and nitinol wire mesh. At least one radiopaque marker band 693 is also included within the distal portion 690d.

6F is a view of a stent support 680 for a sleeve component of an intragastric device, according to one embodiment of the present disclosure. In the embodiment shown, stent support 680 includes a plurality of rings 683 formed from 'Z' shaped segments of wire. In another embodiment, the stent support comprises a continuous spiral wire support and the spiral wire is configured in a 'Z' shape. In one embodiment, the stent support 680 has a similar shape to the pattern 2033 shown in FIG. 20F. Referring again to FIG. 6F, in one embodiment, each ring 683 is connected by a straight wire 684 such that a space 685 will contain only the remaining layers of the sleeve component, with each ring ( 683). In some embodiments, each ring 683 has a length in the range of 1-2 cm. In some embodiments, each connecting straight wire 684 has a length in the range of 1 to 2 inches, and each space 685 also has a length in the range of 1 to 2 inches. In one embodiment, the proximal end of the stent support 680 includes a funnel ring segment 686. In one embodiment, the funnel ring segment 686 includes a sealed connection 687 to the first distal ring 683a. In various embodiments, the funnel ring segment 686 has a diameter dimensioned to match the diameter of the anti-movement component at the distal end of the wire mesh structure to which it will be attached.

FIG. 6G is a view of the sleeve component 688 of the gastric device with the stent support 680 of FIG. 6F. Stent support 680 includes a ring 683 connected by straight wire 684. Another layer 689, such as PTFE of the sleeve component 688, is shown between each set of rings 683. The 'Z' type stent support 680 provides structural integrity to the sleeve component 688 so that the sleeve component 688 is still flexible enough to conform to the curve of the gastrointestinal tract and does not collapse as a result of bowel contraction. to provide.

7 is a diagram of a funnel sleeve 700 for an intragastric device, according to one embodiment of the present disclosure. The sleeve 700 has a funnel shape with a diameter that decreases as the sleeve extends from the first opening 713 at its proximal end to the second opening 719 at its distal end. Sleeve 700 includes at least one wire 702 that is folded by itself to produce a funnel shape having a cross weave pattern. As the sleeve 700 extends distal, its diameter decreases and the intersection of the wires of the cross weave is positioned closer together. Sleeve 700 includes curved or free ends at its proximal and distal ends. The free end is designed to be atraumatic to body tissue. In some embodiments, the first opening 713 has a diameter substantially equal to or slightly larger than the diameter of the anti-movement collar of the wire mesh structure. Sleeve 700 slides over the anti-movement collar and is then secured in place by sealing the free end 714 at the proximal end of the sleeve to a node comprising the anti-movement collar. The free end 718 at the distal end of the sleeve 700 surrounds the second opening 719. In various embodiments, the sleeve 700 is a short sleeve having a total length in the range of 1 cm to 120 cm. In one embodiment, the sleeve 700 is a short sleeve having a total length of 10 cm. In the embodiment shown, the conical funnel section comprises 100% of the sleeve length.

8 is a view of a funnel sleeve 800 for an intragastric device, in accordance with another embodiment of the present disclosure. The sleeve includes a proximal end with a first opening 813 and a distal end with a second opening 819. Sleeve 800 further includes a proximal portion 811 and a distal portion 816. Both the proximal portion 811 and the distal portion 816 of the sleeve 800 are funnel shaped, each having a diameter that decreases as the portions 811, 816 extend distally. The diameter of the proximal portion 811 is the maximum at the proximal end of the sleeve 800, at the position of the first opening 813, until the sleeve 800 transitions from the dislocation point 803 to its distal portion 816. Decreases as 811 extends distally. At the transition point 803, the diameters of the proximal portion 811 and the distal portion 816 are the same. The diameter of the distal portion 816 then decreases as the distal portion 816 extends distally. In other embodiments, the diameter of the distal portion remains the same along its length. In another embodiment, the diameter of the distal portion increases as it extends distally. Distal portion 816 of sleeve 800 terminates at second opening 819 at the distal end of intragastric device 800. The proximal portion includes a first wire 802 that is folded by itself to produce a funnel shape having a first cross-shaped weave pattern. The distal portion includes a second wire 812 that is folded by itself to produce a funnel shape having a second cross-shaped weave pattern. In some embodiments, the second wire 812 is an extension of the first wire 802. In another embodiment, the first wire 802 and the second wire 812 are separate wires connected together at the transition point 803. In one embodiment, the individual wires are spot welded together. In both the proximal portion 811 and the distal portion 816, the cross sections of the wire are closer to each other as the portions 811, 816 extend distal and the funnel shape narrows, so that the weave pattern is separated from each portion 811, It becomes more airtight at the distal end of 816. In one embodiment, the proximal portion 811 has the same weave pattern as the distal portion 816. In other embodiments, the weave pattern of the proximal portion 811 is tighter than the weave pattern of the distal portion 816. In other embodiments, the weave pattern of distal portion 816 is more airtight than the weave pattern of proximal portion 811.

In one embodiment, the proximal portion 811 has a length equal to the length of the distal portion 816. In another embodiment, the proximal portion 811 has a length less than the length of the distal portion 816. In other embodiments, the proximal portion 811 has a length greater than the length of the distal portion 816. Sleeve 800 includes curved or free ends at its proximal and distal ends. The free end is designed to be atraumatic to body tissue. In some embodiments, the first opening 813 has a diameter substantially equal to or slightly smaller than the diameter of the neck of the anti-movement collar of the wire mesh structure. Sleeve 800 slides into the neck of the anti-movement collar and is then secured in place by sealing the free end 814 at the proximal end of the sleeve to the wire junction in the neck of the anti-movement collar. The free end 818 at the distal end of the sleeve 800 surrounds the second opening 819. In various embodiments, the sleeve 800 is a short sleeve having a total length in the range of 1 cm to 120 cm. In one embodiment, the sleeve 800 is a short sleeve having a total length of 10 cm. In the embodiment shown, the conical funnel section comprises 100% of the sleeve length.

9A shows a wire mesh with a sleeve component 944 attached in a post-deployment form according to one embodiment of the present disclosure, showing the blunt end 952 of the wire mesh support toward the proximal end of the sleeve 944. A diagram of the structure 930. The sleeve 944 is connected to a proximally curved non-traumatic anti-collision collar 942 at the distal end of the wire mesh structure 930, and has a four-layer proximal section 945 and a three-layer center section. 955.

9B illustrates a wire mesh structure having a proximal portion of a sleeve component 959 attached in a post-deployment form according to one embodiment of the present disclosure, showing a delivery catheter 969 positioned within the wire mesh structure 957. 957). Sleeve 959 is attached to proximally curved movement preventing component 958.

10A is a view of a funnel braided short sleeve component 1000 in post-deployment form, according to another embodiment of the present disclosure. Sleeve 1000 includes a wired braided structure having a plurality of nodes 1001 at proximal and distal ends of sleeve 1000. Node 1001 is similar in structure to those described with reference to FIG. 3A above and includes free bends unsupported within the wires of the braided structure. In one embodiment, the number of nodes is uniform such that the number of nodes at the proximal end of the sleeve 1000 is equal to the number of nodes at the distal end of the sleeve 1000. In one embodiment, the number of uniform nodes is 24 at both ends. In another embodiment, the number of nodes is variable such that the number of nodes at the proximal end of the sleeve 1000 differs from the number of nodes at the distal end of the sleeve 1000. Any node not present at the distal end of the sleeve is staggered within the body of the sleeve. For example, in one embodiment, the sleeve includes 24 nodes at its proximal end and 18 nodes at its distal end. The remaining six nodes are staggered within the body of the sleeve. In another embodiment, the sleeve includes 24 nodes at its proximal end and 12 nodes at its distal end. The remaining 12 nodes are staggered within the body of the sleeve. Different embodiments include different staggering of the nodes. In one embodiment, the distal portion of the sleeve includes a coating 1002. In various embodiments, approximately 30 to 60 mm of the distal end is covered with coating 1002. In one embodiment, the coating 1002 is silicon. In one embodiment, the staggered nodes are located within the distal portion with the coating 1002 and covered to remove the traumatic surface.

The sleeve 1000 shown in FIG. 10A includes a funnel portion 1005 at its proximal end and a cylindrical portion 1006 at its distal end. In one embodiment, funnel portion 1005 includes a proximal section and a distal section having a length l ₁ . In one embodiment, the length l ₁ is approximately 30 mm. The entire funnel portion has a length l _{2 that} is approximately 60 mm in one embodiment. Cylindrical portion 1006 has a length l _{3 that} is approximately 60 mm in one embodiment. Thus, in one embodiment, the sleeve 1000 has a total length l _i of approximately 120 mm. The sleeve 1000 has a first opening 1003 having a diameter d ₁ at its proximal end. In one embodiment, the diameter d ₁ is approximately 75 mm. The sleeve has a second opening 1004 at its distal end. In various embodiments, the diameter d ₂ of the second opening 1004 is 1 to 30 mm.

FIG. 10B is a view of a funnel braided short sleeve component 1010 having a conical distal end 1017 in a post-deployment form, according to one embodiment of the present disclosure. In various embodiments, the sleeve 1010 consists of a wire braided structure having a plurality of nodes 1011, where the plurality of nodes are uniform or variable as described with reference to FIG. 10A. In one embodiment, the distal portion of the sleeve includes a coating 1012. In various embodiments, approximately 30 to 60 mm of the distal end is covered with coating 1012. In one embodiment, the coating 1012 is silicon. In one embodiment, the staggered nodes are located in the distal portion with the coating 1012 and covered to remove the traumatic surface.

The sleeve 1010 shown in FIG. 10B includes a funnel portion 1015 at its proximal end and a conical portion 1017 at its distal end. In one embodiment, funnel portion 1015 includes a proximal section and a distal section having a length l ₁ . In one embodiment, the length l ₁ is approximately 30 mm. The entire funnel portion has a length l _{2 that} is approximately 60 mm in one embodiment. Cone 1787 has a length l _{3 that} is approximately 55 mm in one embodiment. In one embodiment, a short straight section 1016 of the sleeve is located between the funnel portion 1015 and the cone portion 1017. In one embodiment, the short straight section 1016 has a length of 5 mm. Thus, in one embodiment, the sleeve 1010 has a total length l _i of approximately 120 mm. Sleeve 1010 has a first opening 1013 having a diameter d ₁ at its proximal end. In one embodiment, the diameter d ₁ is approximately 75 mm. The sleeve has a second opening 1014 at its distal end having a diameter d ₂ . In one embodiment, the diameter d ₂ is approximately 10 mm.

FIG. 10C is a view of conical braided short sleeve component 1020 in post-deployment form, in accordance with an embodiment of the present disclosure. In various embodiments, the sleeve 1020 consists of a wire braided structure having a plurality of nodes 1021, where the plurality of nodes are uniform or variable as described with reference to FIG. 10A. In one embodiment, the distal portion of the sleeve includes a coating 1022. In various embodiments, approximately 30 to 60 mm of the distal end is covered with coating 1022. In one embodiment, the coating 1022 is silicon. In one embodiment, staggered nodes are located within the distal portion with coating 1022 and covered to remove the traumatic surface. In one embodiment, the sleeve 1020 has a total length l of approximately 120 mm. Sleeve 1020 has a first opening 1023 having a diameter d ₁ at its proximal end. In one embodiment, the diameter d ₁ is approximately 75 mm. The sleeve has a second opening 1024 having a diameter d ₂ at its distal end. In one embodiment, the diameter d ₂ is approximately 10 mm.

FIG. 10D is a view of the conical braided short sleeve component 1020 of FIG. 10C attached to a wire mesh structure 1030, in accordance with an embodiment of the present disclosure. Referring to FIGS. 10C and 10D simultaneously, the diameter d ₁ of the first opening 1023 of the sleeve 1020 is similarly dimensioned to the diameter of the anti-movement collar 1034 of the wire mesh structure 1030. To attach the wire mesh structure 1030 and the sleeve 1020, the sleeve 1020 slips over the anti-collar collar 1034 and is attached thereto, as indicated by the dashed line 1035. Because these sleeves include a first opening having a similarly dimensioned diameter, the sleeve 1000 and the sleeve 1010 of FIGS. 10A and 10B are each connected to the wire mesh structure in the same manner as the sleeve 1020 of FIG. 10C. Attached. In other words, the sleeves 1000 and 1010 slide over the anti-movement collar of the wire mesh structure.

10E is a view of conical braided short sleeve component 1040 in post-deployment form, in accordance with another embodiment of the present disclosure. Sleeve 1040 is similar to sleeve 1020 of FIG. 10C, except that sleeve 1040 has a smaller first opening 1043. Referring to FIG. 10E, in various embodiments, the sleeve 1040 is comprised of a wire braid structure having a plurality of nodes 1041, where the plurality of nodes are uniform or variable as described with reference to FIG. 10A. . In one embodiment, the distal portion of the sleeve includes a coating 1042. In various embodiments, approximately 30 to 60 mm of the distal end is covered with coating 1042. In one embodiment, the coating 1042 is silicon. In one embodiment, staggered nodes are located within the distal portion with coating 1042 and covered to remove the traumatic surface. In one embodiment, the sleeve 1040 has a total length l of approximately 120 mm. Sleeve 1040 has a first opening 1043 having a diameter d ₁ at its proximal end. In one embodiment, the diameter d ₁ is approximately 30 mm. The sleeve has a second opening 1044 having a diameter d ₂ at its distal end. In one embodiment, the diameter d ₂ is approximately 10 mm.

FIG. 10F is a view of the conical braided short sleeve component 1040 of FIG. 10E attached to a wire mesh structure 1050 according to one embodiment of this disclosure. Referring to FIGS. 10E and 10F simultaneously, the diameter d ₁ of the first opening 1043 of the sleeve 1040 is similar to the diameter of the neck 1052 of the anti-moving collar 1054 of the wire mesh structure 1050. Are dimensioned. The outer diameter of the movement preventing collar 1054 itself is larger than the diameter d ₁ . Thus, to attach the wire mesh structure 1050 and the sleeve 1040, the sleeve 1040 slides into the anti-movement collar 1054 and attaches to the collar neck 1052, as indicated by dashed line 1055. do.

10G and 10H are illustrations of conical braided short sleeve components 1060 and 1065 with non-traumatic distal tips 1062 and 1067 in post-deployment form, according to embodiments herein. Referring to FIGS. 10G and 10H simultaneously, the wires 1061, 1066 of the sleeve components 1060, 1065 do not extend into the distal tip 1062, 1067. The distal tips 1062 and 1067 only include a more flexible sleeve layer, such as PTFE, and are thus atraumatic to the gastrointestinal mucosa. In some embodiments, distal tips 1062 and 1067 have a diameter d ₁ of approximately 10 cm and a length of 5 to 15 cm. In some embodiments, the sleeve components shown in FIGS. 10A-10F each include an atraumatic distal tip similar to those described with reference to FIGS. 10G and 10H.

11A is a cross-sectional view illustrating one embodiment of an intragastric device 1100 having a sleeve 1102 attached in post-deployment form. Device 1100 includes a wire mesh structure 1101 with a collar 1103 located at its distal end. Sleeve 1102 has a cylindrical body with a proximal end attached to the bottom surface of collar 1103. FIG. 11B is a cross-sectional view illustrating the intragastric device 1100 of FIG. 11A in a predeployment form. As the device 1100 is compressed in its predeployment form, the body of the sleeve 1102 is pulled up to assist in folding the collar 1103 of the wire mesh structure 1101. The collar 1103 should be folded so that the device 1100 can have a diameter small enough to fit through the delivery device or catheter. Referring to FIG. 11B, since the proximal end of the sleeve 1102 is attached to the bottom surface of the collar 1103, when the collar 1103 is folded, it is the thickness of the collar 1103 ′ and the thickness of the sleeve 1102 ′, 1102 ") to create an inflation portion that includes twice as much.

11C is a cross-sectional view illustrating another embodiment of an intragastric device 1110 having a sleeve 1112 attached in post-deployment form. The device 1110 includes a wire mesh structure 1111 with a collar 1113 located at its distal end. Sleeve 1112 has a cylindrical body with a funnel proximal end attached to a node or free end at the distal end of collar 1113. Sleeve 1112 is attached to collar 1113 via a plurality of sutures 1117. FIG. 11D is a cross-sectional view illustrating the intragastric device of FIG. 11C in a predeployment form. FIG. As the device 1110 is compressed into its predeployed form, the body of the sleeve 1112 is pulled up to assist in folding the collar 1113 of the wire mesh structure 1111. Sutures 1117 connecting sleeve 1112 to collar 1113 are loosely fixed to allow some minimum movement between sleeve 1112 and collar 1113. Thus, as shown in FIG. 11D, when the collar 1113 is folded, the funnel portion of the sleeve 1112 and the collar 1113 move relative to each other so that the final inflation in the compressed device is merely the thickness of the collar ( 1113 ') only. This creates a smaller cross sectional area or diameter of the compressed device and allows for easier deployment through the delivery device or catheter.

In addition, the collar 1113 shown in FIG. 11C has less sharp bends (rounded) than the collar 1103 shown in FIG. 11A. Less sharp bends in the collar will render the collar atraumatic to body tissue and will maintain its shape because it will have a lower strain.

12A is a view of a plurality of nodes 1205 located at the distal end of a wire mesh structure connected to the proximal end of funnel sleeve 1202, according to one embodiment of the present disclosure. Node 1205 is located at the distal end of the wire mesh structure or at the distal end of the collar, as shown in FIGS. 11C and 11D. Referring to FIG. 12A, each node 1205 is attached to the sleeve 1202 by a suture 1208. As described with reference to FIGS. 11C and 11D, the suture is loosely fixed to allow some movement of the sleeve 1202 relative to the wire mesh structure.

12B is a view of a plurality of nodes 1215 located at the distal end of a wire mesh structure connected to the proximal end of the funnel sleeve 1212, according to another embodiment of the present disclosure. As shown in FIG. 12B, only all other nodes 1215 are attached to the sleeve via sutures 1218. With the wire mesh structure still tightly attached to the sleeve 1212, the reduction in the number of sutures 1218 prior to compression deployment with smaller diameter diameters as compared to the embodiment shown in FIG. 12A. Create a device from the form. Such a compressed device will more easily pass through the delivery device or catheter.

Fastening the suture directly to the distal end of the node may cause too much movement of the sleeve relative to the wire mesh structure as the suture slides along the wire of each node. 12C is a diagram of a plurality of nodes 1225 located at the distal end of a wire mesh structure connected to the proximal end of the funnel sleeve 1222, according to another embodiment of the present disclosure. Instead of placing a suture on the distal end of each node 1225, a suture 1228 is disposed around the intersection 1229 of the wires of two adjacent nodes 1225. This prevents the sliding of the sutures too far along any one wire while still allowing minimal movement of the sleeve 1222 relative to the wire mesh structure during compression.

12D is a view of a plurality of nodes 1235 positioned at the distal end of a wire mesh structure connected to the proximal end of funnel sleeve 1232 according to another embodiment of the present disclosure. As shown in FIG. 12D, only all other intersections 1239 of the wires of adjacent nodes 1235 are attached to the sleeve via sutures 1238. With the wire mesh structure still tightly attached to the sleeve 1232, the reduction in the number of sutures 1238 before compression deployment with smaller diameter diameters as compared to the embodiment shown in FIG. 12C. Create a device from the form. Such a compressed device will more easily pass through the delivery device or catheter.

FIG. 12E is a diagram of a plurality of nodes 1245 positioned at the distal end of a wire mesh structure connected to the proximal end of funnel sleeve 1242, according to another embodiment of the present disclosure. Node 1245 is located at the distal end of the wire mesh structure or at the distal end of the anti-movement collar and includes a loop 1246 formed from the wire of node 1245 and extending in a direction toward the center of the wire mesh structure. . Each loop 1246 of each node 1205 is attached to the sleeve 1242 by sutures 1248.

12F is a diagram of a plurality of nodes 1255 located at the distal end of a wire mesh structure connected to the proximal end of the funnel sleeve 1252, according to another embodiment of the present disclosure. Node 1255 is located at the distal end of the wire mesh structure or at the distal end of the anti-movement collar and includes a loop 1256 formed from the wires of node 1255 and extending in a direction toward the center of the wire mesh structure. . Each loop 1256 of each node 1255 is attached to the sleeve 1252 by sutures 1258. As shown in FIG. 12F, only all other nodes 1255 are attached to the sleeve via sutures 1258. With the wire mesh structure still tightly attached to the sleeve 1252, the reduction in the number of sutures 1258 compared to the embodiment shown in FIG. 12E results in a pre-compressed deployment with an expansion having a smaller diameter. Create a device from the form. Such a compressed device will more easily pass through the delivery device or catheter.

13A is a diagram of a plurality of nodes 1305 located at the distal end of a wire mesh structure connected to the proximal end of the funnel sleeve 1302, according to an embodiment herein. As shown in FIG. 13A, all of the intersection 1309 between some adjacent node 1305 and the end 1304 of some node 1305 is sealed to sleeve 1302 with a knot 1308.

In one embodiment, the distal end of the wire mesh structure is connected to the proximal end of the sleeve at nine independent connection points. Each connection point comprises a number eight knot and heat shrink tube additionally secured by glue. In one embodiment, each knot includes 30 lb breaking strength ultra high molecular weight polyethylene (UHMWPE) to provide a reliable connection between the wire mesh and the sleeve. FIG. 13B is a view of the distal end of the wired mesh structure 1320 and the connected proximal end of the funnel sleeve covered with heat shrink tube 1326, according to one embodiment of the present disclosure.

FIG. 14 is a diagram of an intragastric device 1400 having a funnel sleeve 1410 in post-deployment form, in accordance with an embodiment of the present disclosure. Intragastric device 1400 includes a wire mesh structure 1405 having a proximal end and a distal end having an anti-movement collar 1420 formed at the distal end. Sleeve 1410 includes a proximal end and a distal end, and is attached to anti-movement collar 1420 via the proximal end.

Wire mesh structure 1405 includes at least one metal wire that is folded by itself to produce a cross-shaped weave pattern having a plurality of freely curved ends or nodes along the structure. In its expanded post-deployment form, the wire mesh structure 1405 has an ovoid shape. To facilitate optimal expansion and compression for easier delivery and removal, the wire mesh structure 1405 includes a plurality of staggered nodes 1406, 1407, 1408, 1409 along its length. A first set of staggered nodes 1406 is located at the proximal end of the wire mesh structure 1405 and surrounds the first opening 1401. In one embodiment, the first set of staggered nodes 1406 are curved upwards to extend in opposite directions from the interior of the wire mesh structure 1405. Nodes in the first set of staggered nodes 1406 are used as gripping points for the retrieval device during removal of the gastric device 1400. Wire mesh structure 1405 includes a second set of nodes 1407 staggered distal to the first set 1406 and proximal to the midpoint of the wire mesh structure 1405. A third set of staggered nodes 1408 is located distal to the midpoint and proximal to the distal end of wire mesh structure 1405. A fourth set of staggered nodes 1409 is located at the distal end of the wire mesh structure 1405 and includes a free end of the anti-movement component 1420. All curves including nodes in each set of staggered nodes 1406, 1407, 1408, 1409 are designed to have bends that are atraumatic to body tissue. The nodes are staggered to prevent bulking of the wire bend and bulking of the wire mesh structure as it is compressed to its predeployment form. Expansion of the node along the length of the wire mesh structure allows the entire smaller diameter of the device once compressed.

The sleeve 1410 includes a proximal portion 1411 and a distal portion 1416 connected at the transition point 1415 along the body of the sleeve 1410. Both the proximal portion 1411 and the distal portion 1416 of the sleeve 1410 are funnel shaped, each having a diameter that decreases as the portions 1411, 1416 extend distally. In one embodiment, the diameter of the proximal portion 1411 is substantially the same as the diameter of the anti-movement collar 1420 at the proximal end of the proximal portion 1411. The diameter of the proximal portion 1411 decreases as the proximal portion 1411 extends distally until the sleeve 1410 transitions into its distal portion 1416, at which point the proximal portion 1411 and the distal portion 1416 The diameter is the same. The diameter of the distal portion 1416 then decreases as the distal portion 1416 extends distally. Distal portion 1416 of sleeve 1410 terminates at second opening 1418 at the distal end of intragastric device 1400. In one embodiment, the proximal portion 1411 has a length less than the length of the distal portion 1416. In various embodiments, funnel sleeve 1410 includes at least one wire support. In some embodiments, the at least one wire support comprises the same wire (s) in both the proximal portion 1411 and the distal portion 1416. In another embodiment, the proximal portion 1411 and distal portion 1416 comprise separate wire supports, and the wires are connected together at the distal end of the proximal portion 1411 and the proximal end of the distal portion 1416. In one embodiment, the individual wires are spot welded together. The wire is folded by itself to create a cross weave pattern in the sleeve 1410. In both the proximal portion 1411 and the distal portion 1416, the intersecting sections of the wire are closer to each other as the portions 1411 and 1416 extend distal and the funnel shape narrows, so that the weaving pattern is in each portion 1411,. At the distal end of 1416. Sleeve 1410 includes curved or free ends, similar to the nodes of wire mesh structure 1405 at its proximal and distal ends. The free end is designed to be atraumatic to body tissue. The free end at the proximal end of the sleeve 1410 is attached to the node of the fourth set of staggered nodes 1409 of the wire mesh structure 1405 via one or more sutures 1422. The free end at the distal end of the sleeve 1410 surrounds the second opening 1419. In various embodiments, the sleeve 1410 is a short sleeve having a total length in the range of 5 cm to 120 cm. In one embodiment, the sleeve 1410 is a short sleeve having a total length of 60 cm. In one embodiment, the sleeve 1410 includes a soft atraumatic tip 1430 at its distal end. Tip 1430 does not include wire and is included to prevent damage to the intestinal mucosa from the sleeve tip.

When the sleeve 1410 is attached to the wire mesh structure 1405, the proximal end of the proximal portion 1411 of the sleeve 1410 slides over and covers at least a portion of the anti-movement component 1420, thereby reducing the length of the sleeve 1410. Proximal portion 1411 covers the opening at the distal end of the wire mesh structure. This positioning enables fluid communication between the interior of the wire mesh structure 1405 and the interior of the sleeve 1410, and into the interior of the wire mesh structure 1405 from the first opening 1401. A route for food is established through the interior of 1410 and out of the second opening 1419.

FIG. 15 is a diagram of an intragastric device 1500 having a cylindrical sleeve 1510 in post-deployment form, in accordance with an embodiment of the present disclosure. Intragastric device 1500 includes a wire mesh structure 1505 having a proximal end and a distal end having an anti-movement collar 1520 formed at the distal end. Sleeve 1510 includes a proximal end and a distal end, and is attached to anti-movement collar 1520 via the proximal end. In one embodiment, the sleeve 1510 includes a soft atraumatic tip 1530 at its distal end. Tip 1530 does not include wire and is included to prevent damage to the intestinal mucosa from the sleeve tip.

The wire mesh structure 1505 is similar to the structure 1405 described with reference to FIG. 14 and is in an ovoid shape with a cross weave pattern, a plurality of staggered nodes 1506, 1507, 1508, 1509, and a proximal end thereof. First opening 1501 is included. All curves including nodes in each set of staggered nodes 1506, 1507, 1508, 1509 are designed to have bends that are atraumatic to body tissue.

The sleeve 1510 includes a proximal portion 1511 and a distal portion 1516 connected at the transition point 1515 along the body of the sleeve 1510. The proximal portion 1511 of the sleeve 1510 is funnel shaped and includes a diameter that decreases as the portion 1511 extends distally. In one embodiment, the diameter of the proximal portion 1511 is substantially the same as the diameter of the anti-movement collar 1520 at the proximal end of the proximal portion 1511. The diameter of the proximal portion 1511 decreases as the proximal portion 1511 extends distally until the sleeve 1510 transitions into its distal portion 1516, at which point the proximal portion 1511 and the distal portion 1516 are reduced. The diameter is the same. The diameter of the distal portion 1516 then continues to the same size as the distal portion 1516 extends distally, giving the distal portion 1516 a substantially cylindrical shape. Distal portion 1516 of sleeve 1510 terminates at second opening 1519 at the distal end of intragastric device 1500. In one embodiment, the proximal portion 1511 has a length less than the length of the distal portion 1516.

In various embodiments, the funnel proximal portion 1511 of the sleeve 1510 includes at least one wire support. The wire is folded by itself to create a cross weave pattern in the sleeve 1510. The cross sections of the wire are closer to each other as the portion 1511 extends distal and the funnel shape narrows, so that the weave pattern becomes more airtight at the distal end of the proximal portion 1511. In various embodiments, distal portion 1516 includes at least one helical wire support extending along its cylindrical length. The helical wire support has a constant pitch so that the resulting helical woven structure has the same pattern along the length of the distal portion 1516 of the sleeve 1510. In some embodiments, the helical wire support of distal portion 1516 is an extension of at least one wire support of proximal portion 1511. In another embodiment, the proximal portion 1511 and distal portion 1516 comprise separate wire supports, and the wires are connected together at the distal end of the proximal portion 1511 and the proximal end of the distal portion 1516. In one embodiment, the individual wires are spot welded together. Sleeve 1510 includes a curved or free end, similar to the node of wire mesh structure 1505 at its proximal and distal ends. The free end is designed to be atraumatic to body tissue. The free end at the proximal end of the sleeve 1510 is attached to the node of the fourth set of staggered nodes 1509 of the wire mesh structure 1505 via one or more sutures 1522. The free end at the distal end of the sleeve 1510 surrounds the second opening 1519. In various embodiments, the sleeve 1510 is a short sleeve having a total length in the range of 5 cm to 120 cm. In one embodiment, the sleeve 1510 is a short sleeve having a total length of 60 cm. The funnel conical section may vary from 1% of the total sleeve length to 100% of the total sleeve length.

When the sleeve 1510 is attached to the wire mesh structure 1505, the proximal end of the proximal portion 1511 of the sleeve 1510 slides over the anti-movement component 1520 such that the proximal portion 1511 of the sleeve 1510 is moved. Cover the opening at the distal end of the wire mesh structure. This positioning enables fluid communication between the interior of the wire mesh structure 1505 and the interior of the sleeve 1510, and into the interior of the wire mesh structure 1505 from the first opening 1501. A route for food is established through the interior of 1510 and out of the second opening 1519.

16A is an enlarged view of a funnel sleeve 1602 attached to the anti-moving collar 1604 of the wire mesh structure 1605 of the gastric device 1600, according to one embodiment of the present disclosure. Sleeve 1602 is attached to anti-collision collar 1604 via a plurality of sutures 1608.

16B is an enlarged view of a funnel sleeve 1612 attached to the anti-moving collar 1614 of the wire mesh structure 1615 of the gastric device 1610, in accordance with another embodiment of the present disclosure. Sleeve 1612 attached to anti-collision collar 1614 via a plurality of sutures 1618 includes a plurality of loosened edges 1611 at its proximal end that makes the edge less traumatic to body tissue.

16C is a diagram of an intragastric device 1620 that includes a wire mesh structure 1625 and an attached sleeve 1622, in accordance with an embodiment of the present disclosure. Wire mesh structure 1625 is stationary and includes an atraumatic wire end. In one embodiment, the wire mesh structure 1625 is composed of nitinol. Wire mesh structure 1625 includes an anti-movement collar 1624 to which a sleeve 1622 is attached. In some embodiments, wire mesh structure 1625 includes a retractable tow strap positioned close to its proximal end, as shown with reference to FIG. 16E. The sleeve 1622 includes an apertureless impermeable fluoropolymer liner designed to extend into the proximal portion of the small intestine, particularly the middle duodenum. In various embodiments, the sleeve 1622 includes a nitinol stent structure embedded within the polymer layer such that the sleeve 1622 is atraumatic and no portion of the nitinol is in contact with the small intestine. In one embodiment, the sleeve 1622 includes radiopaque marks for aiding in proper delivery and placement.

Wire mesh structure 1625 is stationary and occupies space within the stomach. The wire mesh structure 1625 is freely floating in the stomach and intermittently exerts mild non-traumatic stretching forces on portions of the stomach as it comes into contact with the internal gastric wall. Stretching forces induce satiety in the patient. The anti-movement collar 1624 is suitably shaped to receive the attached sleeve 1622. The camouflage content enters and attaches to the wire mesh structure 1625 through a first opening 1621 at the proximal end of the wire mesh structure 1625 or through an opening 1629 between the wires of the wire mesh structure 1625. Into the sleeve 1622. The gastrointestinal contents then pass through the sleeve 1622 and are emptied into the duodenum or jejunum from the second opening 1623 at the distal end of the sleeve 1622 along the length of the sleeve 1622. Sleeve 1622 is pre-attached to anti-moving collar 1624 of wire mesh structure 1625. The nitinol stent structure embedded in the sleeve 1622 provides support to the sleeve 1622 and prevents twisting or twisting by the action of the intestinal muscle tissue. Additionally, the nitinol stent structure provides mild radial stretching force on the small intestinal wall, inducing satiety in the patient and preventing the passage of the juice around the sleeve 1622.

FIG. 16D is a diagram of the intragastric device 1620 of FIG. 16C with the sleeve 1622 straightened to show the device 1620 dimensions for the surrounding anatomy. The sleeve 1622 includes a proximal funnel or conical portion 1622p attached to the anti-moving collar of the wire mesh structure 1625 and a distal cylindrical portion 1622d extending distal from the proximal portion 1622p. The wire mesh structure 1625 and the proximal portion 1622p of the sleeve 1622 are configured to be present in the patient's stomach and have a maximum outer diameter and length l ₁ of approximately 8 inches. In some embodiments, the length l ₁ is approximately 10 inches. In some embodiments, the volume of fully developed wire mesh structure 1625 is approximately 1 liter. The proximal portion 1622p of the sleeve 1622 and the distal portion 1622d of the sleeve 1620 meet at a junction 1622j configured to rest on the patient's pylorus. The distal portion 1622d of the sleeve 1620 is configured to be present in the patient's small intestine, particularly the duodenum, and has a maximum outer diameter and length l ₂ of approximately 1.0 inch. In some embodiments, the length l ₂ is approximately 10 to 25 inches. In some embodiments, the length l ₂ of the distal portion 1622d is such that the distal end of the sleeve 1622 is located in the duodenum such that the gastrointestinal contents pass directly from the stomach through the device 1620 and into the duodenum to the pylorus. It is made to bypass. In another embodiment, the length l ₂ is such that the distal end of the sleeve 1622 is located in the factory so that the gastrointestinal contents can pass directly from the stomach through the device 1620 and into the factory to bypass the pylorus and duodenum. Is done. In another embodiment, the wire mesh structure has a maximum diameter of 18 inches, a maximum length of 24 inches, and a maximum volume of 2.5 liters.

16E illustrates a sleeve 1632 of a wire mesh structure 1635 and an intragastric device 1630, showing retractable tow straps 1637, 1638 on the wire mesh structure 1635, according to one embodiment of the present disclosure. Is a drawing. Sleeve 1632 is pre-attached to anti-movement collar 1634 at the distal end of wire mesh structure 1635. In some embodiments, anti-movement collar 1634 includes loops in the wires of the node at the distal end of the node, as shown with reference to FIG. 4C, and sleeve 1632 includes anti-movement collar 1634 in these loops. Sutured to. In the embodiment shown, a pair of retractable tow straps 1637 and 1638 are positioned on the wire mesh structure 1635 proximate its proximal end. A first tow strap 1637 is located at the proximal end of the wire mesh structure 1635, and a second tow strap 1638 is distal to the first tow strap 1637 but still proximal to the wire mesh structure 1635. Located close to the end. Retractable tow straps 1637, 1638 pass through openings between wires of wire mesh structure 1635. During retrieval, the free ends of retrieval tow straps 1637 and 1638 are pulled using a gripper to retract wire mesh structure 1635 to a smaller outer diameter, and thus may be removed from the patient through an endoscope. In one embodiment, the two tow straps 1637 and 1638 are operatively interconnected such that retracting one tow strap causes the other tow strap to simultaneously shrink.

FIG. 16F illustrates a sleeve 1644 of wire mesh structure 1645 and intragastric device 1640, showing a single regenerated drawstring 1648 on the wire mesh structure 1645, according to one embodiment of the present disclosure. Is a drawing. Sleeve 1164 is attached to anti-movement collar 1644 at the distal end of wire mesh structure 1645. In some embodiments, the anti-movement collar 1644 includes loops in the wires of the nodes at the distal ends of the nodes, as shown with reference to FIG. 4C, and the sleeve 1644 is anti-movement collar 1644 in these loops. Sutured to. In the embodiment shown, a single recovery tow strap 1648 is located on the wire mesh structure 1645 proximate its proximal end. Recovery drawstring 1648 passes through openings between the wires of wire mesh structure 1645. During retrieval, the free end of retrieval traction strap 1648 is pulled using a gripper to retract wire mesh structure 1645 to a smaller outer diameter, and thus may be removed from the patient through an endoscope. In the illustrated embodiment, a single retractable tow strap 1648 is provided on the wire mesh structure 1645 at a plurality of nodes 1647, 1649, ie at the proximal end of the wire mesh structure 1645. It is sufficient to retract the second plurality of nodes 1649 at the level of the node 1647 and the drawstring 1648. In other embodiments, a single drawstring is sufficient to retract one or more than two nodes on the wire mesh structure.

In some embodiments where the sleeve comprises a metal wire support, the wire or end of the wires is designed to be atraumatic to body tissue. In various embodiments, the wire ends are dull, folded on the wires, or welded to other wire ends. In another embodiment, the distal end of the sleeve includes a component designed to render the distal end atraumatic to body tissue. FIG. 17A is a cross-sectional view of the distal end of a sleeve 1705 showing an embodiment of component 1710 designed to configure the distal end to be atraumatic to body tissue. Component 1710 is cylindrical in shape with proximal end 1711, distal end 1719, and lumen 1716 therein. Component 1710 is open at both ends 1711, 1719. Lumen 1716 of component 1710 is in fluid communication with lumen 1706 of sleeve 1705 to allow food to pass through the wire mesh of the device, sleeve 1705, and component 1710. Distal end 1719 is rounded to a blunt shape that is atraumatic to body tissue. The outer surface of component 1710 includes a groove 1713 configured to receive a circular member or o-ring 1714. To attach component 1710 to sleeve 1705, the distal end of sleeve 1705 slides coaxially on the proximal end 1711 of component 1710 such that a portion of sleeve 1705 is recessed 1713. ) Will be positioned above. The o-ring 1714 is then disposed on the sleeve 1705 and in the groove 1713, providing a strong connection of the sleeve 1705 to the component 1710. The distal sleeve end 1707 is then folded back in the proximal direction towards the sleeve 1705 body. In one embodiment, component 1710 includes a circular flange 1712 extending outwardly and proximally from an outer surface of component 1710. Flange 1712 covers any sharp end present within folded distal sleeve end 1707 and also serves to protect body tissue from trauma. In various embodiments, component 1710 has a length in the range of 5 mm to 500 mm, an outer diameter in the range of 3 mm to 30 mm, and an inner diameter in the range of 0.5 to 50 mm.

17B is a cross-sectional view of the distal end of the sleeve 1705, illustrating another embodiment of a component 1720 designed to configure the distal end to be atraumatic to body tissue. Component 1720 is cylindrical in shape with proximal end 1721, distal end 1729, and lumen 1726 therein. Component 1720 is open at both ends 1721 and 1729. Lumen 1726 of component 1720 is in fluid communication with lumen 1706 of sleeve 1705 to allow food to pass through the wire mesh, sleeve 1705, and component 1720 of the device. Distal end 1729 is rounded to a blunt shape that is atraumatic to body tissue. The outer surface of component 1720 includes grooves 1723 configured to receive circular members or o-rings 1724. To attach component 1720 to sleeve 1705, the distal end of sleeve 1705 slides coaxially on the proximal end 1721 of component 1720 such that a portion of sleeve 1705 is recessed 1723. ) Will be positioned above. O-ring 1724 is disposed on sleeve 1705 and in groove 1723. The distal sleeve end is then folded back in the proximal direction towards the sleeve 1705 body. A heat shrink tube 1725 is then disposed over the distal sleeve and the O-ring 1724. Heat is applied to the heat shrink tube 1725 to contract the tube 1725 to firmly connect the sleeve 1705 to the component 1720. Any sharp end in the distal sleeve end is included under the heat shrink tube 1725 and is not exposed to body tissue.

FIG. 17C is a cross-sectional view of the distal end of sleeve 1705 illustrating another embodiment of component 1730 designed to configure the distal end to be atraumatic to body tissue. Component 1730 is cylindrical in shape with proximal end 1731, distal end 1739, and lumen 1736 therein. Component 1730 is open at both ends 1731 and 1739. Lumen 1736 of component 1730 is in fluid communication with lumen 1706 of sleeve 1705 to allow food to pass through the wire mesh of the device, sleeve 1705, and component 1730. Distal end 1739 is rounded to a blunt shape that is atraumatic to body tissue. The outer surface of component 1730 includes a groove 1735 configured to receive a circular member or o-ring 1734. To attach the component 1730 to the sleeve 1705, the sleeve 1705 is first turned upside down. The distal end of the sleeve 1705 then slides coaxially over the distal end 1739 of the component 1730 such that a portion of the sleeve 1705 is positioned above the groove 1733. O-ring 1734 is disposed on sleeve 1705 and in groove 1733. The sleeve 1705 is then folded back in the proximal direction over the proximal end 1731 and the O-ring 1734 of the component 1730 to provide a robust connection of the sleeve 1705 to the component 1730. This process of connecting the sleeve 1705 to the component 1730 ensures that the distal sleeve end 1707 will be positioned within the sleeve lumen 1706. Any sharp end in distal sleeve end 1707 is included in sleeve lumen 1706 and is not exposed to body tissue.

18 is a view of the distal end of a sleeve 1805 having a positioning tail 1810 attached thereto, in accordance with an embodiment of the present disclosure. Positioning tail 1810 is attached to the distal end of short sleeve 1805 having a length of 5 mm to 500 mm. Positioning tail 1810 includes a ribbon of material that extends from the distal end of sleeve 1805 into the duodenum of the patient and is used to help maintain proper implant orientation of sleeve 1805 relative to the patient's pylorus. . In various embodiments, positioning tail 1810 has a length l in the range of 5 mm to 500 mm. In one embodiment, the positioning tail 1810 has a length l of 25 mm. In one embodiment, the distal end of positioning tail 1810 includes a bead 1815 for reducing the distal end. In another embodiment, the distal end of the positioning tail includes a plurality of individual free ends similar to horsetails. In another embodiment, the distal end of the positioning tail may be any device or component designed to provide additional weight or pull on the distal end to allow it to be pulled on the tail to ensure proper sleeve orientation. Include. In one embodiment, the distal end of the positioning tail does not include any additional components.

19A is a view of the distal end of a sleeve 1905 that includes a plurality of fringes 1907 coupled to a ring 1908, in accordance with an embodiment of the present disclosure. In various embodiments, the distal end of the sleeve 1905 includes two or more fringes 1907. In one embodiment, the distal end of the sleeve 1905 includes four fringes 1907. Each fringe 1907 includes a portion of sleeve material separated from an adjacent fringe 1907. The fringes 1907 are separated from each other by a space 1906 that allows food passing through the gastric device to exit the sleeve 1905. In various embodiments, each fringe 1907 has a length in the range of 5 mm to 500 mm and a width in the range of 1 mm to 15 mm. In some embodiments, the width of each fringe 1907 decreases as the fringe 1907 extends distally. Fringe 1907 is connected to ring 1908 at the distal end of sleeve 1905. Ring 1908 includes a central opening 1909 for the passage of food. In some embodiments, ring 1908 is semi-rigid. In various embodiments, the ring 1908 has an outer diameter in the range of 1 mm to 30 mm and an inner diameter in the range of 1 mm to 30 mm. In various embodiments, the ring 1908 is attached to each fringe 1907 via closure, gluing, bonding, or any other attachment method. Ring 1908 serves to join fringe 1907 together and to reduce the distal end of sleeve 1905 to assist in proper device orientation. The surface of the ring 1908 is blunted to be atraumatic to body tissues. In some embodiments, fringe 1907 and ring 1908 are parachute shaped.

19B is a view of the distal end of a sleeve 1910 that includes a plurality of fringes 1912 coupled to a ball 1913, according to one embodiment of the present disclosure. In various embodiments, the distal end of sleeve 1910 includes two or more fringes 1912. In one embodiment, the distal end of sleeve 1910 includes four fringes 1912. Each fringe 1912 includes a portion of sleeve material separated from an adjacent fringe 1912. The fringes 1912 are separated from each other by a space 1911 that allows food passing through the intragastric device to exit the sleeve 1910. In various embodiments, each fringe 1912 has a length in the range of 5 mm to 500 mm and a width in the range of 1 mm to 15 mm. In some embodiments, the width of each fringe 1912 decreases as fringe 1912 extends distal. Fringe 1912 is connected to ball 1913 at the distal end of sleeve 1910. In various embodiments, the ball 1913 has a diameter in the range of 2 mm to 30 mm. In various embodiments, the balls 1913 are bonded or bonded to each fringe 1907. The ball 1913 serves to join the fringe 1912 together and reduce the distal end of the sleeve 1910 to assist in proper device orientation. Because the ball 1913 has a spherical shape, it has no sharp edges and is atraumatic to body tissues. In another embodiment, the distal end of fringe 1912 is bound together into a knot to form ball 1913 and no additional ball component is required. In some embodiments, fringe 1912 and ball 1913 are parachute shaped.

In one embodiment, as shown in FIG. 19C, the ball 1913 includes a lumen 1933 to allow passage of the guide wire. In another embodiment, the ball 1913 has a groove or indent 1932 for receiving a plunger or internal pusher catheter of the delivery device. In one embodiment, the circumference of the ball is designed to seat inside the outer catheter of the delivery device.

19D is a view of the distal end of a sleeve 1915 having a plurality of fringes 1917 extending therefrom and coupled to balls 1918, according to one embodiment of the present disclosure. In various embodiments, the sleeve 1915 includes two or more sutures 1917. In one embodiment, the sleeve 1915 includes six seals 1917. In various embodiments, suture 1917 has a length in the range of 5 mm to 500 mm. In one embodiment, suture 1917 is made of nylon. The proximal end of each suture 1917 is attached to the distal end of the sleeve 1915, and the distal end of each suture 1917 is attached to the ball 1918. In various embodiments, the balls 1918 are attached to each suture 1917. In various embodiments, the balls have a diameter in the range of 3 mm to 30 mm. Ball 1918 is designed to add weight to the distal end of sleeve 1915 to pull sleeve 1915 in proper implant orientation. Because the ball 1918 has a spherical shape, it has no sharp edges and is atraumatic to body tissues. The food exits the distal end of the sleeve 1915 and passes through the space 1916 between the sutures 1917. In one embodiment, the ball 1918 includes a central opening 1919 for the passage of the guide wire therethrough. In various embodiments, the ball 1918 is replaced with a ring or similarly designed component to reduce the sleeve 1915 and ensure proper device orientation. In some embodiments, suture 1917 and ball 1918 are parachute shaped.

19E is a view of the distal end of a sleeve 1920 having at least one seal 1922 having attached suture loops or beads 1923 extending therefrom, according to one embodiment of the present disclosure. In one embodiment, the sleeve 1920 includes six seals 1922. In various embodiments, suture 1922 has a length in the range of 5 mm to 500 mm. In one embodiment, the seal 1922 consists of UHMWPE. The proximal end of each suture 1922 is attached to the distal end of the sleeve 1920, and the distal end of each suture 1922 includes an attached suture loop or bead 1923. Suture loops or beads 1923 are designed to add weight to the distal end of sleeve 1920 to pull sleeve 1920 in the proper implant orientation. Since the suture loops or beads 1923 each have a spherical shape, they do not have sharp edges and are atraumatic to body tissues.

20A is a view of the distal end of a sleeve 2005 showing at least one fold 2007 in a sleeve wall 2006, according to one embodiment of the present disclosure. In one embodiment, the sleeve 2005 includes three folds 2007 in its wall 2006. The folds 2007 are created along the longitudinal axis of the sleeve 2005. In various embodiments, the folds 2007 are positioned at equal intervals from each other. Referring to FIG. 20A, the sleeve 2005 itself is folded twice to create three layers of sleeve wall 2006 in each fold 2007. The sleeve layers are bonded to each other at each fold 2007. In one embodiment, the sleeve layers are thermally fused together. Folding of the sleeve wall 2006 creates a corrugated effect that adds structure and stability to the sleeve 2005. The added structure helps to maintain the sleeve 2005 in the proper orientation relative to the pyloric of the patient, and assists in preventing deformation of the sleeve 2005 by the action of the patient's gastrointestinal tract.

20B is a view of the distal end of the sleeve 2010 showing at least one channel 2012 and support structure 2013 in the sleeve wall 2011, according to one embodiment of the present disclosure. In one embodiment, the sleeve 2010 includes four channels 2012 in its walls 2011, and each channel 2012 includes a support structure 2013 therein. In various embodiments, the support structure 2013 includes a tube or bead. In various embodiments, the support structure 2013 is dimensioned to fit snugly within the channel 2012. Channel 2012 extends along the longitudinal axis of sleeve 2010. In one embodiment, the channel 2012 extends the full length of the sleeve 2010. In another embodiment, the channel only extends along the portion of the distal end of the sleeve 2010. In various embodiments, the channels 2012 are located at equal intervals from each other. Inclusion of channel 2012 and support structure 2013 adds structure and stability to sleeve 2010. The added structure helps to maintain the sleeve 2010 in a proper orientation relative to the pyloric of the patient and assists in preventing deformation of the sleeve 2010 by the action of the patient's gastrointestinal tract. In one embodiment, the channel 2012 is a hollow channel that can be filled or expanded with a fluid such as water or air to provide stiffness and / or structure to the sleeve 2010.

20C is a view of a portion of a sleeve 2015 showing a corrugated sleeve wall, according to one embodiment of the present disclosure. Sleeve 2015 includes a plurality of alternating annular grooves 2016 and ridges 2017 extending along its length. In one embodiment, the entire sleeve 2015 is corrugated. In another embodiment, only a portion of the distal end of the sleeve 2015 is corrugated. In various embodiments, the pleats of the sleeve 2015 are comprised of fluoropolymer or polyethylene (PE). Referring to FIG. 20C, in one embodiment, the pleats of the sleeve 2015 are cylindrical and comprise a constant diameter along their entire length. In another embodiment, the pleats of the sleeve are funnel shaped and include a diameter that decreases as the sleeve extends distal. In various embodiments, the distal end of pleated sleeve 2015 is configured to be soft, rounded, and atraumatic to body tissue. The corrugated structure helps to maintain the sleeve 2015 in a proper orientation relative to the pyloric of the patient and assists in preventing deformation of the sleeve 2015 by the action of the patient's gastrointestinal tract.

20D is a view of a portion of sleeve 2020 showing a knitted sleeve wall in accordance with one embodiment of the present disclosure. Sleeve 2020 includes knitted wire pattern 2021 extending along its length. In one embodiment, the entire sleeve 2020 is knitted. In other embodiments, only certain portions, such as the distal end of sleeve 2020, are knitted. Referring to FIG. 20D, in one embodiment, the knitted portion of the sleeve 2020 is cylindrical and includes a constant diameter along its entire length. In various embodiments, the diameter of the sleeve 2020 is in the range of 1 cm to 10 cm. In one embodiment, the diameter of the sleeve is 25 mm and the length is 500 mm. In another embodiment, the knitted portion of the sleeve is funnel shaped and includes a diameter that decreases as the sleeve extends distally. In various embodiments, the distal end of knitted sleeve 2020 is configured to be soft, rounded, and atraumatic to body tissue. The knitted structure helps to maintain the sleeve 2020 in a proper orientation relative to the pyloric of the patient and assists in preventing deformation of the sleeve 2020 by the action of the patient's gastrointestinal tract. Knitted structure provides structural integrity to sleeve 2020 and prevents sleeve 2020 from being twisted, twisted, or blocked. In various embodiments, the sleeve 2020 is high enough to prevent deformation due to peristalsis of the gastrointestinal tract but has a sufficiently low radial force to allow the sleeve 2020 to compress and propagate food through the sleeve 2020. . In addition, the radial force is low enough so that the sleeve is so rigid that it may not cause trauma, including abrasions, to the gastrointestinal tract. In one embodiment, the knitted structure of the sleeve 2020 functions similarly to the stent, such that the sleeve 2020 is properly positioned and held within the small intestine of the patient.

20E is a view of a portion of sleeve 2025 showing the distal sleeve end with knitted sleeve wall and unrolled edge 2028, according to one embodiment of the present disclosure. Sleeve 2025 includes knitted wire pattern 2026 extending along its length. Unrolled edge 2028 at the distal end of sleeve 2025 is less traumatic to body tissue.

20F is a diagram of exemplary sleeve knit patterns 2031, 2032, 2033, 2034, 2035, 2036, 2037, in accordance with various embodiments herein.

21A is a diagram of an intragastric device 2130 having an oval wire mesh structure 2131 deployed in the gastrointestinal tract of a patient, according to one embodiment of the present disclosure. In the embodiment shown, the device 2130 includes a wire mesh structure 2131 having a movement preventing collar 2134 and an attached sleeve 2132. The device 2130 has a wire mesh structure 2131 with the anti-movement collar 2134 positioned just proximal to the pylorus 2161 and the sleeve 2132 extending through the pylorus 2161 into the duodenum 2170. Deployed to be within camouflage 2160. The distal end of the sleeve 2132 is in the duodenum 2170. The anti-movement collar prevents the entire movement of the device 2130 into the duodenum 2170 via the pylorus 2161. The device 2130 occupies the volume of the stomach 2160 and does not move completely past the pylorus 2161, but provides a bypass for food passing through the pylorus 2161 and portions of the duodenum 2170. In various embodiments, the sleeve 2132 is a short sleeve having a length in the range of 5 cm to 120 cm. In one embodiment, the sleeve 2132 is a short sleeve having a total length of 60 cm. In some embodiments, the short sleeve 2132 functions to reduce the wire mesh structure 2131 and orient the wire mesh structure 2131 in the correct direction towards the pyloric 2161. In addition, in one embodiment, the device 2130 with the short sleeve 2132 is able to move freely within the stomach 2160 of the patient after deployment. The short sleeve 2132 is capable of passing back and forth non-traumatically through the pylorus 2161. During the situation when the device 2130 is moved so that the short sleeve 2132 is not located within the pylorus 2161 and duodenum 2170 but rather within the stomach 2160 with the rest of the device 2130, the short sleeve It also functions to disrupt and regulate the flow of food into the pylorus 2161. This is because food enters the device 2130 at the proximal end of the wire mesh structure 2131 and proceeds through the wire mesh structure 2131 and the sleeve 2132, where the passage passes through the funnel sleeve 2132. According to the deceleration. At any time during its proper function, the device is not fixed firmly or permanently to the wall of the gastrointestinal tract. After deployment, during most of its functional time, at least some or all of the device moves freely with respect to the stomach or small intestine. As a result of the included lumen, the device does not completely or permanently block passage of gastrointestinal contents into the small intestine for any clinically meaningful time period at any time during its normal function. Based on the shape of the sleeve, in various embodiments, the device may increase, decrease, or have no effect on gastric emptying.

21B is a diagram of an intragastric device 2140 having an oval wire mesh structure 2141 deployed within the gastrointestinal tract of a patient, according to another embodiment of the present disclosure. The wire mesh structure 2141 is positioned within the stomach 2160 of the patient and includes an anti-movement collar 2144 to which the sleeve 2142 is attached. The sleeve 2142 includes a proximal funnel 2142p that is present in the stomach at the immediate proximal side of the pylorus 2161. The sleeve 2142 also includes a distal cylindrical portion 2142d that passes through the pylorus 2161 and duodenum 2170 and terminates within the jejunum 2172, wherein the gastrointestinal contents passing through the intragastric device 2140. By discharging, it effectively bypasses the pylorus 2161 and duodenum 2170. In another embodiment, the sleeve has a short length and terminates in the duodenum such that the gastrointestinal contents passing through the gastric device bypass only the pyloric and proximal parts of the duodenum. At any time during its proper function, the device is not fixed firmly or permanently to the wall of the gastrointestinal tract. After deployment, during most of its functional time, at least some or all of the device moves freely with respect to the stomach or small intestine. As a result of the included lumen, the device does not completely or permanently block passage of gastrointestinal contents into the small intestine for any clinically meaningful time period at any time during its normal function. Based on the shape of the sleeve, in various embodiments, the device may increase, decrease, or have no effect on gastric emptying.

FIG. 22 illustrates a second intragastric device 2220 coupled to the distal end of the expanded wire mesh structure 2201 of the first intragastric device 2200 and the implant catheter 2250 in a post-deployment form, in accordance with an embodiment of the present disclosure. Is a diagram of a shrunken wire mesh structure 2221. The second intragastric device 2220 also includes a sleeve 2222 coupled to the distal end of the wire mesh structure 2221. The wire mesh structure 2221 and the sleeve 2222 of the second intragastric device 2220 are compressed and slide coaxially over the distal end of the implant catheter 2250. In the illustrated embodiment, the wire mesh structure 2221 and the sleeve 2222 are held in their compressed configuration by a suture line or thread 2225 wound around both the wire mesh structure 2221 and the sleeve. . Once the device 2220 is located in the patient's stomach and duodenum, the suture line or thread 2225 is released and the wire mesh structure 2221 and the sleeve 2222 expand to their deployed configuration. As device 2220 expands, it is released from catheter 2250. Catheter 2250 is then removed from the patient. In another embodiment, the compressed wire mesh structure and sleeve are held in place over the implant catheter via an overlying coaxial sheath. Upon deployment, the sheath is zippered open in the vertical direction, pulled apart or teared to release the device.

FIG. 23 is a diagram of an intragastric device 2300 having a partially shrunk wire mesh structure 2301 on delivery catheter 2350, in accordance with an embodiment of the present disclosure. The device 2300 also includes a combined sleeve 2302 and an anti-moving component 2304. In the embodiment shown, the proximal end of the wire mesh structure 2301 is still shrunk by sutures or threads 2340. The sleeve 2302, the anti-moving component 2304, and the portion of the wire mesh structure 2301 begin to expand because the shrink seal or thread has already been removed from these components.

24A is a diagram of a first exemplary delivery device 2450 for an intragastric device 2400, in accordance with an embodiment of the present disclosure. An intragastric device 2400 comprising a compressed wire mesh structure 2401 and a sleeve 2402 is coaxially positioned with respect to the distal end of the delivery device or catheter 2450. A suture or thread 2440 is wound around the intragastric device 2400 to maintain the intragastric device 2400 in its compressed configuration. The catheter 2450 further includes a thread 2458 in which the suture or thread 2440 used to compress the gastric device 2400 exits the proximal end of the catheter 2450. The surgeon pulls the free end 2459 of the suture or thread 2440 to release the intragastric device 2400. In one embodiment, catheter 2450 also includes a locking mechanism 2455 for locking the device 2450 in place.

24B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 24A, in accordance with an embodiment of the present disclosure. In step 2410, the compressed intragastric device is disposed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscopy into the patient at step 2412 and its distal end is advanced to the duodenum. Next, in step 2414, the distal end of the catheter is positioned such that the wire mesh structure of the gastric device is in the stomach just proximal to the pylorus and the sleeve of the device passes through the pylorus into the duodenum. In step 2416, the surgeon pulls on the free end of the thread to remove the shrinking thread from around the gastric device, causing the gastric device to automatically expand. Finally, at step 2418, the catheter is slid coaxially away from the gastric device and removed from the patient.

25A is a diagram of a second exemplary delivery device 2550 for an intragastric device 2500, in accordance with an embodiment of the present disclosure. An intragastric device 2500 comprising a compressed wire mesh structure 2501 and a sleeve 2502 is coaxially positioned with respect to the distal end of the delivery device or catheter 2550. A zipper closed shrink sheath 2551 is coaxially positioned above the gastric device 2500 to maintain the gastric device 2500 in its compressed configuration.

FIG. 25B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 25A, in accordance with an embodiment of the present disclosure. In step 2510, the compressed intragastric device is disposed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscope into the patient at step 2512 and its distal end is advanced to the duodenum. Next, in step 2514, the distal end of the catheter is positioned such that the wire mesh structure of the gastric device is in the stomach just proximal to the pylorus and the sleeve of the device passes through the pylorus into the duodenum. In step 2516, a work tool is used to zip open the compression sheath from around the gastric device, causing the gastric device to automatically inflate. Finally, at step 2518, the catheter slides coaxially away from the gastric device and is removed from the patient.

Alternatively, sheath 2551 is a standard tubular sheath that is pulled from the gastric device to release the gastric device to the desired position. FIG. 25C is a flowchart illustrating the steps involved in delivering an intragastric device using a delivery device that includes a removable removable sheath, in accordance with an embodiment of the present disclosure. In step 2550, the compressed intragastric device is disposed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscopy into the patient at step 2552 and its distal end is advanced to the duodenum. Next, at step 2554, the distal end of the catheter is positioned such that the wire mesh structure of the gastric device is in the stomach just proximal to the pylori and the sleeve of the device passes through the pylori into the duodenum. In step 2556, a work tool is used to pull the compression sheath coaxially away from the periphery device circumference to allow the intragastric device to automatically expand. Finally, at step 2558, the catheter slides coaxially away from the gastric device and is removed from the patient.

FIG. 26A is a diagram of a third exemplary delivery device 2650 for an intragastric device 2600, in accordance with an embodiment of the present disclosure. An intragastric device 2600 comprising a compressed wire mesh structure 2601 and a sleeve 2602 is coaxially positioned with respect to the distal end of the delivery device or catheter 2650. A tear spaced constricted sheath 2602 is coaxially positioned above the gastric device 2600 to maintain the gastric device 2600 in its compressed configuration.

FIG. 26B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 26A, in accordance with an embodiment of the present disclosure. In step 2610, the compressed intragastric device is disposed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscopy into the patient at step 2612 and its distal end is advanced to the duodenum. Next, at step 2614, the distal end of the catheter is positioned such that the wire mesh structure of the gastrointestinal device is in the stomach just proximal to the pylori and the sleeve of the device passes through the pylori into the duodenum. In step 2616, a work tool is used to tear apart the compression sheath from around the gastric device, causing the gastric device to automatically inflate. Finally, in step 2618, the catheter slides coaxially away from the gastric device and is removed from the patient.

FIG. 26C is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 26A, according to another embodiment of the present disclosure. In step 2620, the compressed intragastric device is disposed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscopy into the patient at step 2622 and its distal end is advanced to the stomach. Next, at step 2624, the distal end of the catheter is positioned such that both the wire mesh structure and the sleeve of the intragastric device are located proximal to the pylorus. In step 2626, a work tool is used to tear apart the compression sheath from around the gastric device, causing the gastric device to automatically inflate. In step 2628, the catheter is coaxially spaced apart from the gastric device and removed from the patient. Finally, in step 2630, the gastrointestinal urges the sleeve of the intragastric device through the pylorus into the duodenum.

FIG. 26D is a flow chart illustrating the steps involved in delivering the wire mesh structure and sleeve separately and assembling the gastric device in the gastrointestinal tract of the patient. In step 2660, the wire mesh structure is delivered into the patient's stomach by the first catheter. Next, at step 2662, the sleeve is delivered into the wire mesh seal by the second catheter. The distal end of the sleeve extends through the distal opening in the wire mesh structure at step 2664. Finally, at step 2666, the proximal end of the sleeve is joined to the distal end of the wire mesh structure.

27A and 27B are diagrams of a fourth exemplary delivery device 2700 for an intragastric device, in accordance with an embodiment of the present disclosure. The delivery device 2700 includes a flexible elongated device body, or an external catheter 2704 having a proximal end, distal end, and lumen therein. The distal end includes an opening 2703, and the proximal end is attached to the first handle 2705. First handle 2705 is used to position delivery device 2700 within the gastrointestinal tract of the patient. The flexible plunger component 2716 is located coaxially and longitudinally movable within the lumen of the device body 2704. Plunger 2716 includes a proximal end, a distal end, and also includes a lumen therein. Distal tip 2714 of plunger 2716 includes mesh retaining component 2725 that includes a plurality of pins 2715. The pins 2715 hold the wire mesh structure 2701 of the gastric device securely, and act to squeeze and pull the wire mesh structure 2701 as the plunger 2716 moves back and forth within the device body 2704. . A second handle 2706 is located at the proximal end of the plunger 2716 to move the plunger 2716 in the longitudinal direction within the lumen of the device body 2704. Optionally, in one embodiment, plunger 2716 includes a stopper 2718 that prevents plunger 2716 from moving too far in the distal direction. The flexible elongated rod, or internal catheter 2713, is coaxially located within the lumen of the plunger 2716 and is movable longitudinally. The rod 2713 includes a proximal end and a distal end. A first spherical component or olive 2708 is located proximal to the distal end of rod 2725 and a second spherical component or olive 2709 is located at distal end of rod 2725. The first spherical component or olive 2708 has a diameter similar to or greater than that of the second spherical component or olive 2709. Attached to the proximal end of the rod 2713 is a third handle 2707 that is used to move the rod 2725 in the longitudinal direction within the lumen of the plunger 2716. An intragastric device comprising a wire mesh structure 2701 and a sleeve 2702 is positioned within the delivery device 2700 prior to deployment. Wire mesh structure 2701 is disposed with side loops around rod 2725 and distal to tip 2714 of plunger 2716, and portions of wire mesh structure 2701 are fins of tip 2714. 2715) is hooked on. In some embodiments, rod 2725 passes through at least two openings in wire mesh structure 2701, wherein the openings do not lie along the central longitudinal axis of wire mesh structure 2701. In one embodiment, wire mesh structure 2701 is compressed for positioning within delivery device 2700 to have a compressed length of approximately 20 cm. Sleeve 2702 attached to wire mesh structure 2701 is located distal to wire mesh structure 2701 and proximal to first spherical component or olive 2708. Sleeve 2702 is folded by itself 2 to 10 times and then wound around rod 2725. In one embodiment, the sleeve 2702 has a length of 80 cm and is folded three times by itself to produce a compressed length of approximately 30 cm. Sleeve 2702 is not coaxially passed over rod 2725. First and second ends of suture loops 2713 are attached to sleeve 2702, respectively, and looped to rod 2725 at a position distal to first spherical component or olive 2708. The diameter of the suture loop 2713 around the rod is smaller than the diameter of the first spherical component or olive 2708 but greater than the diameter of the second spherical component or olive 2709. When rod 2725 is extruded out of device body 2704, first spherical component or olive 2708 urges suture loop 2713, which grabs attached sleeve 2702 out of device body 2704. Pull. Delivery-Biodegradable. In other embodiments, suture loops 2713 are biodegradable hooks, rings, cones, or umbrellas.

Optionally, in one embodiment, the delivery device 2700 further includes a balloon 2710 at the distal end of the device body 2704. Channel 2711 extends along the length of device body 2704 and includes an input port 2712 at the proximal end of device body 2704. Balloon 2710 is inflated using input port 2712 and channel 2711 to secure the delivery device in the gastrointestinal tract of the patient. Fixation provides greater traction to the delivery device to allow compression and traction during delivery of the intragastric device.

In some embodiments, delivery device 2700 further includes a flushing or perfusion mechanism to reduce deployment force during delivery.

In various embodiments, the delivery device or catheter has varying stiffness along its length. The delivery device is more flexible at its distal end and less flexible along its length toward its proximal end. In some embodiments, the delivery device has three flexible zones: the proximal zone, the central zone, and the distal zone. In one embodiment, the proximal zone is 100 cm long and 55D flexible, the central zone is 20 cm long and 40D flexible, and the distal zone is 30 cm long and 35D flexible. Optionally, in one embodiment, the distal zone is divided into two additional zones, including a more distal zone and a less distal zone. Both zones are 15 cm in length, the less distal zones have a flexibility of 35D, while the more distal zones have a flexibility of 25D. In one embodiment, the proximal zone is braided and the central and distal zones are wound up.

The delivery device includes an atraumatic distal end, and the three handle system of the delivery device allows for a shorter overall device body length. In various embodiments, referring to FIG. 27B, the delivery device may have the following dimensions: an overall length in the range of 275 cm to 320 cm; The length of the device body or outer catheter 2704 in the range of 100 cm to 150 cm; The length of the plunger 2716 in the range of 120 cm to 150 cm; The length of the rod or inner catheter 2725 in the range of 275 cm to 320 cm; The length of each handle 2705, 2706, 2707 that is 10 cm; A distance between the second spherical component or olive 2709 and the first spherical component or olive 2708 in the range of 15 cm to 30 cm; A distance between the first handle 2705 and the second handle 2706 when in initial configuration prior to delivery at 60 cm; And a distance between the second handle 2706 and the third handle 2707 when in initial configuration before delivery that is 50 cm. In some embodiments, the outer diameter of the device body or outer catheter 2704 is 10 mm or less. In one embodiment, the delivery device is deployable over a 0.035 inch guide wire. In various embodiments, plunger 2716 and rod 2717 are sufficiently flexible to allow atraumatic bowel control. In some embodiments, the solid outer catheter is bent to 80 degrees and it is possible to steer a curve having a radius of 30 mm to 50 mm. In an embodiment, if the solid outer catheter is wound with a radius of approximately 50 mm, the sleeve and mesh will not be twisted or tightened in place and will not deploy. Thus, as shown in FIG. 27C, in some embodiments, the device body or external catheter 2704 includes a flexible braided catheter. Flexible braided catheter is capable of bending and winding beyond the aforementioned limits without causing failure of the sleeve and wire mesh deployment.

FIG. 27C is a view of the distal end of delivery device 2700 showing pilot olive, or first spherical component 2709 for steering, in accordance with an embodiment of the present disclosure. Pilot olive 2709 includes a small sphere having a blunt outer surface attached to the rod of delivery device 2700 or the distal end of inner catheter 2717. Pilot olive 2709 guides device 2700 during delivery and prevents twisting of device 2700 and trauma to surrounding body tissue. Referring to FIG. 27C, the portion of the inner catheter 2725 extending from the outer catheter 2704 includes a pilot component. The stiffness of the pilot component is lower than the stiffness of the distal portion of the outer catheter 2704. In some embodiments, the pilot component has variable stiffness with a stiffness of the distal end of the outer catheter 2704 at its proximal end and a stiffness close to that of the 0.035 "guide wire at its distal end.

FIG. 27D is a diagram of a portion of the delivery device 2700 showing mesh retaining component 2725, in accordance with an embodiment of the present disclosure. Mesh retaining component 2719 includes a plurality of pins 2715. The pins 2715 hold the wire mesh structure of the intragastric device firmly and serve to press and pull the wire mesh structure as the plunger 2716 is moved back and forth within the device body 2704.

In one embodiment, the sleeve is only partially deployed during delivery. The wire mesh structure serves as a fixture for positioning the device. As the patient eats, the sleeve expands and develops fully due to movement of the gastrointestinal tract.

FIG. 27E is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 27A, in accordance with an embodiment of the present disclosure. In step 2720, the delivery device slides over the guide wire into a position in the gastrointestinal tract of the patient. In step 2721, the physician positions the distal end of the delivery device body within the duodenum of the patient using the first handle. Optionally, in step 2722, the surgeon inflates the balloon at the distal end of the device body to secure the delivery device in the gastrointestinal tract of the patient. The surgeon then presses the second handle in step 2723 to indent the plunger component until the sleeve is extruded out of the device body. Optionally, the plunger includes a stopper, thus recognizing when the doctor stops pressing the second handle. At this point, the sleeve is advanced approximately 20 cm, passes the first spherical component and is located directly proximal to the second spherical component. The wire mesh structure is located directly proximal to the opening at the distal end of the first spherical component and the device body. Next, at step 2724, the surgeon squeezes the third handle to advance the rod approximately 60 cm within the lumen of the plunger until the sleeve is fully deployed and fully stretched or uncompressed. In step 2725, the surgeon relocates the device by pulling it back approximately 5-10 cm so that the distal end of the funnel section of the sleeve is in the stomach. Next, at step 2726, the surgeon pulls the first handle backward while maintaining the second handle firmly to deploy the funnel section of the sleeve and the wire mesh structure within the stomach. This pulls the device body back while keeping the plunger in place, thus releasing the wire mesh structure. The delivery device is then removed from the patient in step 2727 to leave the gastric device in a sieve deployed within the patient's gastrointestinal tract.

28A is a diagram of a fifth exemplary delivery device 2830 for an intragastric device, in accordance with an embodiment of the present disclosure. The delivery device 2830 includes a flexible elongated device body, or an external catheter 2834 having a proximal end, distal end, and lumen therein. The distal end includes an opening 2833, and the proximal end is attached to the actuation mechanism 2835. Actuator 2835 includes actuator handle 2849 and actuator trigger 2848 and is used to move the components of the delivery device relative to each other. The actuation mechanism is also used to position the delivery device 2830 within the gastrointestinal tract of the patient. The flexible plunger component 2846 is coaxially located in the lumen of the device body 2834 and movable longitudinally. Plunger 2846 includes a proximal end, a distal end, and also includes a lumen therein. Distal tip 2844 of plunger 2846 includes mesh retaining component 2819 that includes a plurality of pins 2845. Fins 2845 hold the wire mesh structure 2831 of the gastric device firmly and serve to squeeze and tow the wire mesh structure 2831 as the plunger 2846 is moved back and forth within the device body 2834. . The proximal end of the plunger 2846 is located in the actuation mechanism, where pulling the actuation trigger 2848 causes the plunger 2846 to move back and forth longitudinally within the lumen of the device body 2834. The flexible elongated rod, or internal catheter 2847, is located within the lumen of the plunger 2846. Rod 2847 includes a proximal end and a distal end. A first spherical component or olive 2838 is located proximal to the distal end of rod 2847 and a second spherical component or olive 2839 is located at the distal end of rod 2847. Olives 2838 and 2839 include spherical attachments to assist in the delivery of the intragastric device. The first spherical component or olive 2838 has a larger diameter than that of the second spherical component or olive 2839. Attached to the proximal end of the rod 2847 is a rod handle 2837 that is used to move the rod 2847 in the longitudinal direction within the lumen of the plunger 2846. An intragastric device comprising a wire mesh structure 2831 and a sleeve 2832 is located within the delivery device 2830 prior to deployment. In various embodiments, the sleeve is compressed coaxially. In another embodiment, the sleeve is not compressed coaxially. The wire mesh structure 2831 is disposed with side loops around the rod 2847 and distal to the tip 2844 of the plunger 2846, and a portion of the wire mesh structure 2831 is formed by the pins of the tips 2844. Hooked onto 2845. A sleeve 2832 attached to the wire mesh structure 2831 is positioned distal to the wire mesh structure 2831 and proximal to the first spherical component or olive 2838. The sleeve 2832 itself is folded 2 to 10 times and then wound around the rod 2847. Sleeve 2832 does not pass coaxially over rod 2847. A suture loop 2843 is attached to the sleeve 2832 and looped to the rod 2847 at a position distal to the first spherical component or olive 2838. The diameter of the suture loop 2843 around the rod 2847 is smaller than the diameter of the first spherical component or the olive 2838 but larger than the diameter of the second spherical component or the olive 2839. When rod 2847 is extruded out of device body 2834, first spherical component or olive 2838 presses suture loop 2843, which grabs attached sleeve 2832 out of device body 2834. Pull. When the delivery device 2830 is removed from the patient's gastrointestinal tract along with the rod 2847, the suture loop 2843 slips over the second, smaller diameter spherical component or olive 2839 so that the intragastric device remains in the patient. To be. In one embodiment, suture loop 2843 is biodegradable and dissolves over time. In other embodiments, suture loops 2843 are biodegradable hooks, rings, cones, or umbrellas.

Optionally, in one embodiment, the delivery device 2830 further includes a balloon 2840 at the distal end of the device body 2834. Channel 2841 extends along the length of device body 2834 and includes an input port 2842 at the proximal end of device body 2834. Balloon 2840 is inflated using input port 2842 and channel 2841 to secure the delivery device within the gastrointestinal tract of the patient. Fixation provides greater traction to the delivery device to allow compression and traction during delivery of the intragastric device.

FIG. 28B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 28A, in accordance with an embodiment of the present disclosure. In step 2850, the delivery device slides over the guide wire into a position in the gastrointestinal tract of the patient. In step 2851, the surgeon uses the actuation instrument to position the distal end of the delivery device body within the duodenum of the patient. Optionally, in step 2852, the surgeon inflates the balloon at the distal end of the device body to secure the delivery device in the gastrointestinal tract of the patient. The surgeon then in step 2853 pulls the activation trigger until the first locking, indenting the rod handle. Optionally, the plunger includes a stopper, thus recognizing when the doctor stops pressing the second handle. At this point, the sleeve is advanced approximately 20 cm, passes the first spherical component and is located directly proximal to the second spherical component. The wire mesh structure is located directly proximal to the opening at the distal end of the first spherical component and the device body. Optionally, in step 2854, the surgeon advances the plunger approximately 60 cm until the sleeve is fully deployed and fully stretched or uncompressed. In step 2855, the surgeon relocates the device by pulling it back approximately 5-10 cm so that the distal end of the funnel section of the sleeve is in the stomach. Next, in step 2856, the physician pulls the activation trigger again until it is locked twice. This pulls the device body back while keeping the plunger in place, thus releasing the funnel section and the wire mesh structure of the sleeve. The delivery device is then removed from the patient in step 2857, leaving the gastric device in a sieve deployed within the patient's gastrointestinal tract.

29A is a diagram of another exemplary delivery device 2900 for an intragastric device, in accordance with an embodiment of the present disclosure. The delivery device 2900 of FIG. 29A includes only two handles 2905 and 2906 and a device body or external catheter 2904 and a rod or internal catheter 2917, the delivery device shown in FIG. 27A. (2700). The delivery device 2900 of FIG. 29A does not include an individual plunger with its own handle. Instead, the plunger 2916 is integrated with the second handle 2906 and coaxially encloses the proximal portion of the inner catheter 2917. The delivery device 2900 includes a flexible elongated device body, or an external catheter 2904 having a proximal end, distal end, and lumen therein. The distal end includes an opening 2907, and the proximal end is attached to the first handle 2905. First handle 2905 is used to position delivery device 2900 in the gastrointestinal tract of the patient. In one embodiment, the first handle 2905 includes a Y-connector. The flexible elongated rod, or inner catheter 2917, is coaxially located within the lumen of the outer catheter 2904 and is movable longitudinally. The rod 2917 includes a proximal end and a distal end attached to the second handle 2906. The flexible plunger component 2916 is coaxially positioned over the proximal portion of the inner catheter 2917 and moves longitudinally therewith. Plunger 2916 includes a proximal end and a distal end that are also attached to second handle 2906. The distal tip of the plunger 2916 includes a mesh retaining component 2919 that includes a plurality of pins 2915. The pin 2915 holds the wire mesh structure 2901 of the gastric device firmly and compresses the wire mesh structure 2901 as the plunger 2916 and the inner catheter 2917 move back and forth within the outer catheter 2904. And towing. The second handle 2906 is located at the proximal end of the plunger 2916 and the inner catheter 2917 to longitudinally move the plunger 2916 and the inner catheter 2917 within the lumen of the outer catheter 2904. Optionally, in one embodiment, the plunger includes a stopper that prevents the plunger and the inner catheter from moving too far in the distal direction. A first spherical component or olive 2908 is located proximal to the distal end of the inner catheter 2917 and a second spherical component or olive 2909 is located at the distal end of the inner catheter 2917. The first spherical component or olive 2908 has a larger diameter than that of the second spherical component or olive 2909. An intragastric device comprising a wire mesh structure 2901 and a sleeve 2902 is positioned within the delivery device 2900 prior to deployment. Wire mesh structure 2901 is disposed with side loops around rod 2917 and distal to the tip of plunger 2916, and portions of wire mesh structure 2901 are pins 2915 of retaining component 2919. It is hooked on). In some embodiments, rod 2917 passes through at least two openings in wire mesh structure 2901, where the openings do not lie along the central longitudinal axis of wire mesh structure 2901. In one embodiment, wire mesh structure 2901 is compressed for positioning within delivery device 2900 to have a compressed length of approximately 30 cm. Sleeve 2902 attached to wire mesh structure 2901 is located distal to wire mesh structure 2901 and proximal to first spherical component or olive 2908. Sleeve 2902 is folded by itself 2 to 10 times and then wound around inner catheter 2917. In one embodiment, the sleeve 2902 has a length of 80 cm and is folded three times by itself to produce a compressed length of approximately 30 cm. Sleeve 2902 does not pass coaxially over inner catheter 2917. The first and second ends of the suture loop 2913 are attached to the sleeve 2902, respectively, and looped to the inner catheter 2917 at a position distal to the first spherical component or olive 2908. The diameter of the suture loop 2913 around the rod is smaller than the diameter of the first spherical component or olive 2908 but larger than the diameter of the second spherical component or olive 2909. When the inner catheter 2917 is extruded out of the outer catheter 2904, the first spherical component or olive 2908 urges the suture loop 2913, which attaches the attached sleeve 2902 to the outer catheter 2904. Pull on. When the delivery device 2900 is removed from the patient's gastrointestinal tract with the internal catheter 2917, the suture loop 2913 slips onto the second, smaller diameter spherical component or olive 2909 such that the intragastric device is in the patient. To remain. In one embodiment, suture loop 2913 is biodegradable and dissolves over time. In other embodiments, suture loops 2913 are biodegradable hooks, rings, cones, or umbrellas.

Optionally, in one embodiment, the delivery device 2900 further includes a balloon at the distal end of the device body. The channel extends along the length of the device body and includes an input port at the proximal end of the device body. The balloon is inflated using input ports and channels to secure the delivery device within the gastrointestinal tract of the patient. Fixation provides greater traction to the delivery device to allow compression and traction during delivery of the intragastric device.

In some embodiments, delivery device 2900 further includes a flushing or perfusion mechanism to reduce deployment force during delivery.

In various embodiments, the delivery device or catheter has varying stiffness along its length. The delivery device is more flexible at its distal end and less flexible along its length toward its proximal end. In some embodiments, the delivery device has three flexible zones: the proximal zone, the central zone, and the distal zone. In one embodiment, the proximal zone is 100 cm long and 55D flexible, the central zone is 20 cm long and 40D flexible, and the distal zone is 30 cm long and 35D flexible. Optionally, in one embodiment, the distal zone is divided into two additional zones, including a more distal zone and a less distal zone. Both zones are 15 cm in length, the less distal zones have a flexibility of 35D, while the more distal zones have a flexibility of 25D. In one embodiment, the proximal zone is braided and the central and distal zones are wound up.

The delivery device includes an atraumatic distal end, and the two-handle system of the delivery device allows for a shorter overall device body length. In various embodiments, the delivery device has the following dimensions: an overall length in the range of 265 cm to 310 cm; The length of the device body or outer catheter 2904 in the range of 100 cm to 150 cm; The length of the plunger 2916 in the range of 120 cm to 150 cm; The length of the rod or inner catheter 2917 in the range of 265 cm to 310 cm; The length of each handle 2905, 2906, 2907 that is 10 cm; A distance between the second spherical component or olive 2909 and the first spherical component or olive 2908 in the range of 15 cm to 30 cm; And a distance between the first handle 2905 and the second handle 2906 when in initial configuration before delivery that is 110 cm. In some embodiments, the outer diameter of the device body or outer catheter 2904 is 10 mm or less. In one embodiment, the delivery device is deployable over a 0.035 inch guide wire. In various embodiments, plunger 2916 and internal catheter 2917 are sufficiently flexible to allow non-traumatic bowel control. In some embodiments, the solid outer catheter is bent to 80 degrees and it is possible to steer a curve having a radius of 30 mm to 50 mm. In an embodiment, if the solid outer catheter is wound with a radius of approximately 50 mm, the sleeve and mesh will not be twisted or tightened in place and will not deploy. Thus, in some embodiments, the outer catheter 2904 includes a flexible braided catheter. Flexible braided catheter is capable of bending and winding beyond the aforementioned limits without causing failure of the sleeve and wire mesh deployment.

In one embodiment, the sleeve is only partially deployed during delivery. The wire mesh structure serves as a fixture for positioning the device. As the patient eats, the sleeve expands and develops fully due to movement of the gastrointestinal tract.

In some embodiments, the outer catheter has an internal catheter coaxially located within the outer catheter and has varying stiffness along its length and includes a lumen for receiving the atraumatic distal end and the guiding device. Prior to delivery, the intragastric device is located in the space between the inner and outer catheter. The inner catheter further includes a flexible extension having a length of at least 5 cm at its distal end extending beyond the distal end of the outer catheter. In some embodiments, the guide device is a guide wire. In another embodiment, the guidance device is an endoscope for over the scope delivery. In some embodiments, the atraumatic distal end of the inner catheter is a ball-tip. In some embodiments, the internal catheter has varying stiffness along its length. In some embodiments, the flexible extension includes a proximal end and a distal end and has varying stiffness along its length, the stiffness being between the stiffness of the guide wire at the distal end and the stiffness of the inner catheter at the proximal end. Fluctuates. In another embodiment, the stiffness of the flexible extension is constant along its length.

FIG. 29B is a cross-sectional view of a pre-deployed coaxial arrangement of sleeve 2935 of an intragastric device in delivery device 2930, according to one embodiment of the present disclosure. The delivery device 2930 includes an internal catheter 2333 coaxially located within the lumen 2936 of the external catheter 2937. Internal catheter 2333 includes a guide wire port 2932 for insertion of a guide wire to assist in guiding delivery. In various embodiments, the guide wire is a super rigid guide wire having a diameter in the range of 0.035 to 0.038 inch. In the arrangement shown in FIG. 29B, the sleeve 2935 is shown around the inner catheter 2933 such that the inner catheter 2333 is located within the lumen 2934 of the sleeve 2935.

29C is a cross-sectional view of a pre-coaxial coaxial arrangement of sleeve 2935 of an intragastric device in delivery device 2930, according to another embodiment of the present disclosure. The delivery device 2930 includes an internal catheter 2333 coaxially located within the lumen 2936 of the external catheter 2937. Internal catheter 2333 includes a guide wire port 2932 for insertion of a guide wire to assist in guiding delivery. In the arrangement shown in FIG. 29C, the sleeve 2935 is shown adjacent to the inner catheter 2333 so that the inner catheter 2333 is located outside the lumen 2934 of the sleeve 2935.

FIG. 29D is a cross-sectional view of a pre-deployed coaxial arrangement of the sleeve 2935 of the intragastric device in the delivery device 2930 shown above the endoscope 2939, according to one embodiment of the present disclosure. The delivery device 2930 includes an internal catheter 2333 coaxially located within the lumen 2936 of the external catheter 2937. The internal catheter 2933 includes an endoscope port 2938 in which an endoscope 2939 is located to assist in guiding delivery. In the arrangement shown in FIG. 29D, the sleeve 2935 is shown around the inner catheter 2333 so that the inner catheter 2333 is located within the lumen 2934 of the sleeve 2935.

In some embodiments, a system for delivering an intragastric device to a gastrointestinal tract of a patient includes a porous mesh structure having a first lumen; A sleeve attached to the porous mesh structure and having a second lumen; And a coaxial catheter system including an outer catheter and an inner catheter, wherein prior to delivery, the porous mesh structure and the sleeve are bound into a space between the outer and inner catheter, the outer catheter covering a substantial portion of the intragastric device and Inner catheter passes within most of the first lumen of the mesh but outside of most of the second lumen of the sleeve. In some embodiments, the inner catheter is operatively attached to the sleeve at the distal end of the inner catheter such that, in operation, the inner catheter extrudes the sleeve out of the coaxial catheter system and then detached from the sleeve to deliver the intragastric device into the gastrointestinal tract. do.

FIG. 29E is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 29A, in accordance with an embodiment of the present disclosure. In step 2920, the delivery device slides over the guide wire into a position in the gastrointestinal tract of the patient. In step 2921, the surgeon uses the first handle to position the distal end of the delivery device body within the duodenum of the patient. Optionally, in step 2922, the surgeon inflates the balloon at the distal end of the device body to secure the delivery device in the gastrointestinal tract of the patient. The surgeon then pushes the second handle (approximately 60 cm) in step 2923 to advance the plunger and internal catheter until the sleeve is extruded out of the delivery device body and fully deployed. Optionally, the plunger includes a stopper, thus recognizing when the doctor stops pressing the second handle. In step 2924, the surgeon relocates the device by pulling it back approximately 5-10 cm so that the distal end of the funnel section of the sleeve is in the stomach. Next, at step 2925, the surgeon pulls the first handle backward while maintaining the second handle firmly to deploy the funnel section of the sleeve and the wire mesh structure within the stomach. This pulls the device body back while keeping the plunger and internal catheter in place, thus releasing the wire mesh structure. The delivery device is then removed from the patient in step 2926 to leave the intragastric device deployed in a sieve deployed within the patient's gastrointestinal tract.

30A is a diagram of a seventh exemplary delivery device 3000 for an intragastric device, in accordance with an embodiment of the present disclosure. The delivery device 3000 includes a coaxial delivery system having a flexible outer catheter 3002 and a flexible inner catheter 3001 shaft onto which the intragastric device is preloaded. External catheter 3002 includes proximal and distal ends and lumens therein. The inner catheter 3001 is located within the lumen of the outer catheter 3002 and also includes the proximal and distal ends and lumens therein. The lumen of the inner catheter 3001 is configured to receive the guide wire. In various embodiments, the delivery device 3000 is approximately 3 meters in length and is used to orally deliver an intragastric device into the patient's stomach and duodenum or jejunum. The delivery device 3000 has a variable stiffness along its length that also provides sufficient flexibility for tracking through the small intestine loop while also having sufficient compressibility to prevent gastric loop formation. In various embodiments, the outer catheter 3002 has a length of approximately 1.5 meters. In some embodiments, the distal portion of outer catheter 3002 includes a lubricating hydrophilic coating that can be activated immediately prior to delivery for easy manipulation. In one embodiment, the coating covers approximately distal 0.65 meters of outer catheter 3002. The proximal end of the device 3000 includes a proximal portion of the inner catheter 3001 that is not covered by the outer catheter 3002. A pair of stop mechanisms 3004, 3006 are positioned on the inner catheter 3001 as further described with reference to FIGS. 30E and 30G. A first handle 3003 having a proximal end, a distal end, and a lumen configured to receive the guide wire is attached to the proximal end of the inner catheter 3001. A second handle 3008 having a proximal end, distal end, and lumen configured to receive the inner catheter 3001 is attached to the proximal end of the outer catheter 3002 and coaxially around the inner catheter 3001. It is slidably positioned above. Movement of the second handle 3008 to the proximal and distal sides relative to the first handle 3003 causes the outer catheter 3002 to slide over the inner catheter 3001 to the proximal and distal sides.

Pilot component 3007 extends distal from the distal end of internal catheter 3001. The pilot component includes an elongate super flexible rod having a proximal end and a distal end. The proximal end of the pilot component includes a proximal spherical component, or olive, as described below with reference to FIGS. 30D and 30E. The distal end of pilot component 3007 includes a distal spherical component, or olive, as further described below with reference to FIGS. 30D and 30F. In some embodiments, pilot component 3007 is also covered with a lubricious hydrophilic coating.

30B is a diagram of an exemplary embodiment of an external catheter 3050 for use in the delivery device of FIG. 30A. Outer catheter 3050 includes three segments of varying stiffness, each having a proximal end, distal end, and lumen: proximal segment 3051, center segment 3052, and distal segment 3053. A second handle 3054 is attached to the proximal end of the proximal segment 3051. A soft tip 3055 is attached to the distal end of distal segment 3053. Both the second handle 3054 and the soft tip 3055 include a lumen for receiving an internal catheter. In one embodiment, the outer catheter 3050 is connected from the junction of the first radiopaque marker 3056 and the proximal segment 3051 and the central segment 3052 to the junction of the distal segment 3053 and the flexible tip 3055. And a second radiopaque marker 3057 on center segment 3052 that is approximately 4-6 cm. In various embodiments, the proximal segment 3051 has a length of approximately 85 cm and a stiffness of 120% of the stiffness of the central segment 3052. In various embodiments, the center segment 3052 has a length in the range of approximately 52 to 54 cm. In various embodiments, distal segment 3053 has a length in the range of approximately 11 to 13 cm and a stiffness of 80% of the stiffness of central segment 3052. In various embodiments, the outer catheter 3050 has an overall length in the range of 150-152 cm, including no second handle 3054 or soft tip 3055. In one embodiment, the second handle 3054 has a length of 10 cm. In one embodiment, the soft tip 3055 has a length of 0.5 cm. During delivery, the second handle 3054 is located outside the body of the patient. In some embodiments, during delivery, approximately proximal 50 cm of proximal segment 3051 is located in the esophagus. In some embodiments, during delivery, approximately distal 35 cm of proximal segment 3051 and proximal 4-6 cm of central segment 3052 are located within the stomach. In some embodiments, during delivery, approximately distal 48 cm of the center segment 3052 and the entire distal segment 3053 and soft tip 3055 are located in the intestine.

30C is a diagram of another embodiment of an outer catheter 3070 showing the dimensions of the compressed sleeve 3062 and the compressed wire mesh structure 3031 of the gastric device 3060 relative to the dimensions of the external catheter 3070. . The outer catheter 3070 of FIG. 30C includes only the proximal segment 3071 and the distal segment 3073. The distal segment 3073 has a length in the range of 63 to 67 cm, with 59 to 61 cm located in the intestine and 4 to 6 cm located in the stomach. Compressed sleeve 3062 has a length in the range of 54-56 cm, is fully contained within distal segment 3073 and is fully positioned within the intestine. Compressed wire mesh structure 3031 has a length in the range of approximately 29 to 31 cm. Approximately 9-11 cm of the wire mesh structure 3041 is received within the proximal end of the distal segment 3073 and 19-21 cm of the wire mesh structure 3041 is received within the distal end of the proximal segment 3071. . Approximately 4 to 6 cm of the wire mesh structure 3031 is located in the intestine, and 24 to 26 cm of the wire mesh structure is located in the stomach.

FIG. 30D is an enlarged view of the distal end of the delivery device 3000 of FIG. 30A, showing the pilot component 3007 and the proximal and distal spherical components 3011, 3013. The proximal spherical component 3011 is shaped to be atraumatic and includes a radiopaque marker 3012 for radiographic visualization during delivery. Distal spherical component 3013 is configured in a ball-tip shape and is also designed to be atraumatic to body tissue. The design of pilot component 3007 and proximal and distal spherical components 3011, 3013 are configured to facilitate non-traumatic over-the-guide wire tracking through the long loop. The stiffness of the pilot component 3007 is lower than the stiffness of the distal portion of the outer catheter. In some embodiments, the pilot component 3007 has variable stiffness with a stiffness close to the stiffness of the distal end of the outer catheter at its proximal end and a stiffness of the 0.035 "guide wire at its distal end.

FIG. 30E is a view of the proximal end of the delivery device of FIG. 30A, showing the external catheter 3002 being retracted into the first stop mechanism 3004. During delivery of the intragastric device that is preloaded on the delivery device, the user may use the second catheter 3001 to retract or proximal the outer catheter 3002 over the inner catheter 3001 while using the second catheter 3001. Hold first handle 3003 firmly to hold in place. The outer catheter 3002 is retracted until the proximal end of the second handle 3008 contacts the first stop mechanism 3004. The second stop mechanism 3006 is also located on the inner catheter 3001 proximal to the first stop mechanism 3004. In some embodiments, stop mechanisms 3004 and 3006 include plastic rings rigidly secured to the inner catheter using wing nuts 3004a and 3006a. In some embodiments, the first handle 3003 includes a first port 3013 for the injection of a fluid, such as saline or water, to flush the lumen of the inner catheter 3001. In some embodiments, the second handle 3008 includes a second port 3018 for injection of a fluid, such as saline or water, to flush the lumen of the outer catheter 3002.

FIG. 30F is a diagram of one embodiment of a sleeve 3022 of the intragastric device deployed partially in response to the position of the outer catheter 3002 shown in FIG. 30E. Referring to FIGS. 30E and 30F simultaneously, when the outer catheter 3002 is retracted such that the proximal end of the second handle 3008 is in contact with the first stop mechanism 3004, the sleeve 3022 is shown in FIG. 30F. It is partially developed as shown. The portion of deployed sleeve 3022 is a cylindrical distal portion 1622d as described with reference to FIG. 16D. This is part of the sleeve 3022 present in the small intestine of the patient. The outer catheter 3002 is retracted to the junction point 1622j of the sleeve described in FIG. 16D. As shown in FIG. 30F, in some embodiments, the sleeve 3022 is coaxially wound around the inner catheter 3001 of the delivery device. In other words, the inner catheter 3001 does not pass through the lumen of the sleeve 3022. In one embodiment, the distal end of the outer catheter 3002 includes a radiopaque marker 3009 to ensure proper placement of the delivery device under radiographic visualization.

FIG. 30G is a view of the proximal end of the delivery device of FIG. 30A, showing the external catheter 3002 being retracted with the second stop mechanism 3006. The first stop mechanism has been removed to allow for further retraction of the outer catheter 3002. Continuing delivery of the intragastric device, the user may use the first handle (3) to hold the inner catheter 3001 in place while using the second handle 3008 to further retract the outer catheter 3002 above the inner catheter 3001. 3003) firmly. The outer catheter 3002 is retracted until the proximal end of the second handle 3008 contacts the second stop mechanism 3006.

30H is a diagram of one embodiment of a wire mesh structure 3021 of an intragastric device that is partially deployed corresponding to the position of the outer catheter 3002 shown in FIG. 30G. Referring to FIGS. 30G and 30H simultaneously, when the outer catheter 3002 is retracted such that the proximal end of the second handle 3008 is in contact with the second stop mechanism 3006, the wire mesh structure 3021 is shown in FIG. 30H. It is partially developed as shown in FIG. The movement preventing collar 3024 of the wire mesh structure 3021 is unfolded, and as a result of its shape memory characteristics, it is reversed from its predeployment form to its postdeployment form as shown in FIG. 11D. The proximal end of the fully deployed sleeve 3022 is now shown attached to the anti-moving collar 3024. As shown in FIG. 30H, in some embodiments, the inner catheter 3001 is passed through the spaces between the wires of the wire mesh structure 3021 along the side of the structure 3021. In other words, the inner catheter 3001 does not pass through the center of the wire mesh structure 3021.

FIG. 30I is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 26A, in accordance with an embodiment of the present disclosure. In step 3030, optionally, the distal end of the delivery device is wetted to activate the lubricity hydrophilic coating, which will facilitate insertion and manipulation of the delivery device. The delivery device then slides into the patient's gastrointestinal tract over the guide wire in step 3032. Perspective examination is used in step 3034 to determine the position of the distal end of the outer catheter to ensure accurate positioning of the delivery device. While the first handle is held firmly to hold the inner catheter in place, in step 3036, the outer catheter is deployed to position and deploy a portion of the sleeve of the gastric device preloaded in the tenon of the patient's gastrointestinal tract. Retreat to Next, in step 3038, the entire delivery device is retracted until the distal end of the outer catheter is positioned directly in proximity to the pylorus. In step 3040, the first stop mechanism is removed from the internal catheter. While the first handle is firmly held to hold the inner catheter in place, in step 3042, the outer catheter is first positioned to deploy and position the portion of the sleeve of the gastric device and the portion of the wire mesh structure within the gastrointestinal tract of the patient's gastrointestinal tract. 2 Retreat to the stop mechanism. In step 3044, the second stop mechanism is removed from the internal catheter. While the first handle is firmly held to hold the inner catheter in place, in step 3046, the outer catheter is retracted to the first handle to deploy and position portions of all wire mesh structures within the gastrointestinal tract of the patient's gastrointestinal tract. In step 3048, the delivery device is removed from the patient.

FIG. 31A is a diagram of a wire mesh structure 3101 of an intragastric device 3100 loaded on a delivery device, in accordance with an embodiment of the present disclosure. Referring to FIG. 31A, a portion of an internal catheter 3131 and a pilot component 3137 of a delivery device are shown. The delivery device includes a proximal spherical component 3135 at the transition from the internal catheter 3101 to the pilot component 3137. Wire mesh structure 3101 includes a sleeve 3102 attached to its anti-collision collar 3104. When loading the gastric device 3100 on the delivery device, the pilot component 3137 is passed through an off-axis opening between the wires of the wire mesh structure 3101 such that the proximal spherical component 3135 is transferred to the wire mesh structure 3101. ) And the inner catheter 3131 lies within the inner volume of the wire mesh structure 3101.

FIG. 31B is a view of the wire mesh structure 3101 of FIG. 31A also loaded on the delivery device. The proximal end of the wire mesh structure 3101 is compressed and is now received within the distal end of the outer catheter 3132 of the delivery device. The proximal spherical component is no longer visible as the wire mesh structure 3101 advances proximally along the inner catheter 3131. Referring to FIG. 31B, the inner catheter is shown exiting the wire mesh structure 3101 through an opening offset from the center of the wire mesh structure 3101. The sleeve is then wound coaxially around the inner catheter as described with reference to FIG. 31C. In another embodiment, the inner catheter (and attached pilot component) continues within the wire mesh structure and exits through an opening in the side of the proximal funnel portion of the sleeve. In another embodiment, the inner catheter continues in the wire mesh structure and exits through an opening in the side of the distal cylindrical portion of the sleeve. In another embodiment, the inner catheter continues within the wire mesh structure, passes through the entire sleeve, and exits through an opening in the distal end of the sleeve.

FIG. 31C is a view of the wire mesh structure 3101 of FIG. 31A loaded on the delivery device such that only the anti-moving collar 3104 remains loaded. FIG. 31D is a view of the wire mesh structure of FIG. 31A fully loaded on the delivery device. FIG. Referring to FIG. 31D, the wire mesh structure is no longer visualized as it is fully received within the distal end of the outer catheter 3132. Sleeve 3102 is shown wound coaxially around inner catheter 3131.

FIG. 31E is a view of the sleeve 3102 of the intragastric device of FIG. 31A partially loaded on the delivery device. A portion of the sleeve 3102 wound coaxially around the inner catheter 3131 is visualized as extending from the distal end of the outer catheter 3132. FIG. 31F is a view of the intragastric device of FIG. 31A fully loaded on the delivery device. FIG. Proximal spherical component 3135 is located at the distal end of outer catheter 3132. In one embodiment, a plurality of sutures 3105 extending from the distal end of the sleeve are tied against the proximal spherical component 3135 to hold the intragastric device in place until ready for delivery. Prior to delivery, the suture 3105 is released so that the intragastric device may be deployed.

32A is a diagram of a retrieval device 3200 for removing an intragastric device, in accordance with another embodiment of the present disclosure. The retrieval device 3200 includes a flexible outer tube 3202 that includes an elongated body having a proximal end, a distal end, and a lumen therein. First handle 3212 is attached to the proximal end and opening 3222 is located at the distal end of outer tube 3202. A flexible inner member 3204 comprising an elongated body having a proximal end and a distal end is disposed within the lumen of the outer tube 3202. In one embodiment, the inner member 3204 comprises a flexible metal wire. A second handle 3214 is attached to the proximal end and a recovery mechanism 3224 is formed from the distal end of the inner member 3204. In one embodiment, retrieval mechanism 3224 includes a hook. In one embodiment, the hook is lockable.

FIG. 32B is a flowchart illustrating the steps involved in removing an intragastric device from a patient using the retrieval device of FIG. 32A, in accordance with an embodiment of the present disclosure. In step 3232, the surgeon inserts an outer tube of the retrieval device into the operating channel of the endoscope inserted in the patient. At this point, the retrieval mechanism at the distal end of the inner member is received within the distal end of the outer tube. In step 3234, the surgeon securely holds the first handle to position the retrieval device in the gastrointestinal tract of the patient. Next, at step 3236, the surgeon urges the second handle to extend the recovery mechanism through the opening beyond the distal end of the outer tube. In step 3238, the surgeon manipulates the second handle to grasp the proximal end of the intragastric device by the retrieval mechanism. In one embodiment, the proximal end of the intragastric device includes a set of staggered nodes, as shown as node 1615 with reference to FIG. 16B for easy gripping by the retrieval mechanism. Once the gastric device is secured by the retrieval mechanism, in step 3240, the surgeon pulls the second handle to pull at least a portion of the retrieval mechanism and the attached intragastric device into the distal end of the outer tube. The gastrointestinal device is made of a shape memory metal and can be easily compressed to a size that can be inserted into the outer tube. Optionally, in step 3242, the surgeon operates the locking mechanism on the retrieval device to prevent the retrieval mechanism and attached gastric device from slipping out of the distal end of the outer tube. Finally, in step 3244, the physician removes the retrieval device and the attached intragastric device from the patient.

It is to be understood that the present disclosure is intended to provide a teaching of a number of exemplary embodiments of the invention and should not be limited to the specific structures disclosed herein. Other variations of the disclosed embodiments that can be understood by those skilled in the art are within the scope of the invention as covered by the present application and further defined by the claims.

201: wire mesh structure 203: recovery mechanism
204: anti-movement collar 210: wire mesh structure
215: end 216, 218: node
301, 302: multiple nodes 308: loop
320: wire mesh structure 420: intragastric device

Claims (20)

A delivery device for delivering a gastrointestinal tract device into a gastrointestinal tract of a patient, the gastrointestinal tract device comprising a porous structure configurable between a compressed pre-expanded form and an expanded post-deployment form, an anti-movement collar proximate the distal end of the porous structure, and An elongated sleeve coupled to the distal end of the porous structure, the delivery device comprising:
A flexible outer catheter having a proximal end, a distal end, and a lumen; And
Flexible internal catheter having a proximal end, distal end, and lumen configured to slidably receive the guide wire
Wherein the inner catheter is configured to be coaxially positioned and slidably moved within the lumen of the outer catheter,
And the outer catheter is configured to retract in the proximal direction above the inner catheter while holding the inner catheter in place to expose the gastrointestinal device from the distal end of the delivery device. 2. The sleeve of claim 1, wherein the sleeve is of a length such that when the gastrointestinal device is delivered, the proximal end of the sleeve is positioned proximal to the patient's pylorus and the distal end of the sleeve is positioned within a portion of the duodenum of the patient. The delivery device. The delivery device of claim 1, wherein the external catheter has a length of 1.5 meters and the delivery device has a total length of 3 meters. The method of claim 1,
A first handle attached to the proximal end of the inner catheter and having a lumen configured to slidably receive the proximal end, the distal end, and the guide wire;
A second handle attached to the proximal end of the outer catheter and having a proximal end, a distal end, and a lumen configured to slidably receive the inner catheter, the first handle and the second handle prior to delivery of the gastrointestinal tract device; A second handle wherein the proximal portion of the inner catheter positioned between the handles is exposed and not covered by the outer catheter;
An elongate flexible pilot component having a proximal end, a distal end, and a length with varying stiffness, the pilot component comprising a distal spherical component and a proximal spherical component and extending from the distal end of the inner catheter An elongate flexible pilot component;
A first stop mechanism removably attached to an exposed portion of the proximal portion of the inner catheter; And
A second stop mechanism removably attached to the exposed portion of the internal catheter and positioned in proximity to the first stop mechanism
And the first and second stop mechanisms are configured to be sequentially removed from the inner catheter when the outer catheter is retracted. 5. The method of claim 4, further comprising a hydrophilic coating on at least one of the pilot component and the distal end of the outer catheter, wherein the hydrophilic coating is adapted to facilitate insertion and manipulation of the delivery device when activated. Delivery device. The method of claim 4, wherein
A port on at least one of said first handle for injecting fluid into said lumen of said inner catheter and said second handle for injecting fluid into said lumen of said outer catheter
The delivery device further comprising. The delivery device of claim 4, wherein the proximal spherical component is configured to be atraumatic and includes a radiopaque marker for radiographic visualization during delivery. The delivery device of claim 4, wherein the distal spherical component is configured in an atraumatic ball-tip shape. 5. The delivery device of claim 4, wherein the variable stiffness of the pilot component is less than the stiffness of the distal end of the outer catheter at its proximal end and is similar to the stiffness of the 0.035 inch guide wire at its distal end. delete delete delete delete delete delete delete A delivery system for delivering a gastrointestinal tract device into a gastrointestinal tract of a patient,
Comprising a gastrointestinal tract device and a delivery device,
The gastrointestinal tract device,
A porous structure configurable between the compressed pre-deployed form and the expanded post-deployed form;
A movement preventing collar proximate the distal end of the porous structure; And
An elongated sleeve coupled to the distal end of the porous structure,
The delivery device,
A flexible outer catheter having a proximal end, a distal end, and a lumen;
A flexible inner catheter having a proximal end, a distal end, and a lumen configured to slidably receive a guide wire, the inner catheter being positioned coaxially and slidably movable within the lumen of the outer catheter. Flexible internal catheter;
A first handle attached to the proximal end of the inner catheter and having a lumen configured to slidably receive the proximal end, the distal end, and the guide wire;
A second handle attached to the proximal end of the outer catheter and having a proximal end, a distal end, and a lumen configured to slidably receive the inner catheter, the inner positioned between the first handle and the second handle The proximal portion of the catheter may include a second handle, the entirety of which is not covered by the outer catheter;
An elongate flexible component comprising a distal spherical component and a proximal spherical component extending from the distal end of the inner catheter;
A first stop mechanism removably attached to an exposed portion of the proximal portion of the inner catheter; And
A second stop mechanism removably attached to the exposed portion of the internal catheter and positioned in proximity to the first stop mechanism
Wherein the distal end of the inner catheter is adapted to pass through the opening of the porous structure, the sleeve is wound coaxially with respect to the inner catheter, and the outer catheter holds the inner catheter in place while the inner Retracted proximally above the catheter, the first and second stop mechanisms being sequentially removed from the inner catheter when the outer catheter is retracted to expose and deliver the gastrointestinal device from the distal end of the delivery device. Delivery system. 18. The method of claim 17, further comprising a hydrophilic coating over at least one of the elongate flexible component and the distal end of the outer catheter, wherein the hydrophilic coating facilitates insertion and manipulation of the delivery device when activated. Delivery system that is supposed to be. The method of claim 17,
A port on at least one of said first handle for injecting fluid into said lumen of said inner catheter and said second handle for injecting fluid into said lumen of said outer catheter
Delivery system further comprising. 18. The delivery system of claim 17, wherein the delivery device has a variable stiffness along its length.

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